| 06/01/2023 |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
ANDA #204801 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
MACLEODS PHARMS LTD |
|
Approval |
| 06/01/2023 |
ARIKAYCE KIT
NDA #207356 |
SUPPL-13 |
AMIKACIN SULFATE |
INSMED INC |
Labeling |
Approval |
| 06/01/2023 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #214283 |
ORIG-1 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
BPI LABS |
|
Approval |
| 06/01/2023 |
PREGABALIN
ANDA #214496 |
ORIG-1 |
PREGABALIN |
EPIC PHARMA LLC |
|
Approval |
| 06/01/2023 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #214576 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
EUGIA PHARMA SPECLTS |
|
Tentative Approval |
| 06/01/2023 |
DICYCLOMINE HYDROCHLORIDE
ANDA #216782 |
ORIG-1 |
DICYCLOMINE HYDROCHLORIDE |
TWI PHARMS |
|
Approval |
| 06/02/2023 |
CIPROFLOXACIN HYDROCHLORIDE
ANDA #077689 |
SUPPL-2 |
CIPROFLOXACIN HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 06/02/2023 |
OMEPRAZOLE MAGNESIUM
ANDA #078878 |
SUPPL-28 |
OMEPRAZOLE MAGNESIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 06/02/2023 |
OMEPRAZOLE MAGNESIUM
ANDA #078878 |
SUPPL-30 |
OMEPRAZOLE MAGNESIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 06/02/2023 |
OMEPRAZOLE MAGNESIUM
ANDA #078878 |
SUPPL-32 |
OMEPRAZOLE MAGNESIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 06/02/2023 |
OMEPRAZOLE MAGNESIUM
ANDA #078878 |
SUPPL-42 |
OMEPRAZOLE MAGNESIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 06/02/2023 |
TACROLIMUS
ANDA #200744 |
SUPPL-11 |
TACROLIMUS |
FOUGERA PHARMS INC |
Labeling |
Approval |
| 06/02/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201066 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 06/02/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633 |
SUPPL-30 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 06/02/2023 |
LARIN 1/20
ANDA #202995 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 06/02/2023 |
LARIN 1/20
ANDA #202995 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 06/02/2023 |
LARIN 1/20
ANDA #202995 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 06/02/2023 |
ANORO ELLIPTA
NDA #203975 |
SUPPL-15 |
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 06/02/2023 |
PITAVASTATIN CALCIUM
ANDA #206015 |
SUPPL-6 |
PITAVASTATIN CALCIUM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/02/2023 |
PITAVASTATIN CALCIUM
ANDA #206015 |
SUPPL-7 |
PITAVASTATIN CALCIUM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/02/2023 |
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #206137 |
SUPPL-6 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
PAR PHARM INC |
Labeling |
Approval |
| 06/02/2023 |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #207630 |
SUPPL-1 |
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
EUGIA PHARMA |
Manufacturing (CMC) |
Approval |
| 06/02/2023 |
RABEPRAZOLE SODIUM
ANDA #208644 |
SUPPL-16 |
RABEPRAZOLE SODIUM |
ALKEM LABS LTD |
Labeling |
Approval |
| 06/02/2023 |
TRELEGY ELLIPTA
NDA #209482 |
SUPPL-18 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 06/02/2023 |
NADOLOL
ANDA #211763 |
ORIG-1 |
NADOLOL |
ALEMBIC |
|
Approval |
| 06/02/2023 |
NALOXONE HYDROCHLORIDE
ANDA #213279 |
SUPPL-3 |
NALOXONE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 06/02/2023 |
NALOXONE HYDROCHLORIDE
ANDA #213279 |
SUPPL-5 |
NALOXONE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 06/02/2023 |
LAMPIT
NDA #213464 |
SUPPL-5 |
NIFURTIMOX |
BAYER HEALTHCARE |
Efficacy |
Approval |
| 06/02/2023 |
EPLERENONE
ANDA #213812 |
ORIG-1 |
EPLERENONE |
ANNORA PHARMA |
|
Approval |
| 06/02/2023 |
MINOCYCLINE
ANDA #214934 |
ORIG-1 |
MINOCYCLINE |
NEXUS PHARMS |
|
Tentative Approval |
| 06/02/2023 |
NELARABINE
ANDA #215057 |
ORIG-1 |
NELARABINE |
NEXUS |
|
Approval |
| 06/02/2023 |
TICAGRELOR
ANDA #217328 |
ORIG-1 |
TICAGRELOR |
ANNORA PHARMA |
|
Tentative Approval |
| 06/02/2023 |
ADBRY
BLA #761180 |
SUPPL-5 |
TRALOKINUMAB |
LEO PHARMA AS |
|
Approval |
| 06/05/2023 |
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020163 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020163 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020163 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020183 |
SUPPL-29 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020183 |
SUPPL-29 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #020183 |
SUPPL-29 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020183 |
SUPPL-29 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
DEFINITY
NDA #021064 |
SUPPL-32 |
PERFLUTREN |
LANTHEUS MEDCL |
Labeling |
Approval |
| 06/05/2023 |
DEFINITY RT
NDA #021064 |
SUPPL-32 |
PERFLUTREN |
LANTHEUS MEDCL |
Labeling |
Approval |
| 06/05/2023 |
PACLITAXEL
ANDA #076131 |
SUPPL-30 |
PACLITAXEL |
HOSPIRA |
Manufacturing (CMC) |
Approval |
| 06/05/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201760 |
SUPPL-33 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 06/05/2023 |
QUETIAPINE FUMARATE
ANDA #202152 |
SUPPL-17 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
QUETIAPINE FUMARATE
ANDA #202152 |
SUPPL-19 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
QUETIAPINE FUMARATE
ANDA #202152 |
SUPPL-20 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
QUETIAPINE FUMARATE
ANDA #202152 |
SUPPL-21 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 06/05/2023 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #204230 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
APOTEX |
|
Approval |
| 06/05/2023 |
DESIPRAMINE HYDROCHLORIDE
ANDA #208105 |
SUPPL-7 |
DESIPRAMINE HYDROCHLORIDE |
AMNEAL PHARMS CO |
Labeling |
Approval |
| 06/05/2023 |
PREVYMIS
NDA #209939 |
SUPPL-12 |
LETERMOVIR |
MERCK SHARP DOHME |
Efficacy |
Approval |
| 06/05/2023 |
PREVYMIS
NDA #209940 |
SUPPL-11 |
LETERMOVIR |
MERCK SHARP DOHME |
Efficacy |
Approval |
| 06/05/2023 |
ORILISSA
NDA #210450 |
SUPPL-9 |
ELAGOLIX SODIUM |
ABBVIE |
Labeling |
Approval |
| 06/05/2023 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #211001 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
KINDOS |
|
Approval |
| 06/05/2023 |
SPY AGENT GREEN KIT
NDA #211580 |
SUPPL-6 |
INDOCYANINE GREEN |
NOVADAQ TECH |
Efficacy |
Approval |
| 06/05/2023 |
ZOLEDRONIC ACID
ANDA #213371 |
ORIG-1 |
ZOLEDRONIC ACID |
MEITHEAL |
|
Approval |
| 06/05/2023 |
ORIAHNN (COPACKAGED)
NDA #213388 |
SUPPL-3 |
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM |
ABBVIE |
Labeling |
Approval |
| 06/05/2023 |
FOSCARNET SODIUM
ANDA #213807 |
ORIG-1 |
FOSCARNET SODIUM |
AVET LIFESCIENCES |
|
Approval |
| 06/05/2023 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #214739 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
| 06/06/2023 |
TRACLEER
NDA #021290 |
SUPPL-42 |
BOSENTAN |
ACTELION |
Labeling |
Approval |
| 06/06/2023 |
RENVELA
NDA #022127 |
SUPPL-21 |
SEVELAMER CARBONATE |
SANOFI |
Labeling |
Approval |
| 06/06/2023 |
CEFDINIR
ANDA #065332 |
SUPPL-17 |
CEFDINIR |
TEVA PHARMS |
Labeling |
Approval |
| 06/06/2023 |
KETOCONAZOLE
ANDA #075912 |
SUPPL-15 |
KETOCONAZOLE |
SENORES PHARMS |
Labeling |
Approval |
| 06/06/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #078789 |
SUPPL-7 |
VENLAFAXINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 06/06/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #078789 |
SUPPL-8 |
VENLAFAXINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 06/06/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #078789 |
SUPPL-10 |
VENLAFAXINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 06/06/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #078789 |
SUPPL-11 |
VENLAFAXINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 06/06/2023 |
MYCOPHENOLATE MOFETIL
ANDA #090111 |
SUPPL-13 |
MYCOPHENOLATE MOFETIL |
STRIDES PHARMA |
Labeling |
Approval |
| 06/06/2023 |
MYCOPHENOLATE MOFETIL
ANDA #090111 |
SUPPL-14 |
MYCOPHENOLATE MOFETIL |
STRIDES PHARMA |
Labeling |
Approval |
| 06/06/2023 |
ALENDRONATE SODIUM
ANDA #090124 |
SUPPL-16 |
ALENDRONATE SODIUM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/06/2023 |
SUMATRIPTAN SUCCINATE
ANDA #090358 |
SUPPL-29 |
SUMATRIPTAN SUCCINATE |
SUN PHARM |
Labeling |
Approval |
| 06/06/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203326 |
SUPPL-30 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 06/06/2023 |
ACETAZOLAMIDE
ANDA #203434 |
SUPPL-3 |
ACETAZOLAMIDE |
NOVAST LABS |
Labeling |
Approval |
| 06/06/2023 |
ACETAZOLAMIDE
ANDA #204691 |
SUPPL-9 |
ACETAZOLAMIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
| 06/06/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #205694 |
SUPPL-11 |
VANCOMYCIN HYDROCHLORIDE |
GLAND PHARMA LTD |
Manufacturing (CMC) |
Approval |
| 06/06/2023 |
NITROGLYCERIN
ANDA #208191 |
SUPPL-1 |
NITROGLYCERIN |
DR REDDYS |
Labeling |
Approval |
| 06/06/2023 |
NITROGLYCERIN
ANDA #208191 |
SUPPL-2 |
NITROGLYCERIN |
DR REDDYS |
Labeling |
Approval |
| 06/06/2023 |
NITROGLYCERIN
ANDA #208191 |
SUPPL-4 |
NITROGLYCERIN |
DR REDDYS |
Labeling |
Approval |
| 06/06/2023 |
ROFLUMILAST
ANDA #208299 |
SUPPL-1 |
ROFLUMILAST |
PRINSTON INC |
Labeling |
Approval |
| 06/06/2023 |
KETOCONAZOLE
ANDA #210457 |
SUPPL-2 |
KETOCONAZOLE |
STRIDES PHARMA |
Labeling |
Approval |
| 06/06/2023 |
SOLIFENACIN SUCCINATE
ANDA #211622 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
LANNETT CO INC |
|
Approval |
| 06/06/2023 |
TADALAFIL
ANDA #212515 |
ORIG-1 |
TADALAFIL |
ZYDUS PHARMS |
|
Approval |
| 06/06/2023 |
DAPSONE
ANDA #213907 |
ORIG-1 |
DAPSONE |
BELOTECA |
|
Approval |
| 06/06/2023 |
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #214646 |
ORIG-1 |
ENOXAPARIN SODIUM |
BE PHARMS |
|
Approval |
| 06/06/2023 |
HEPARIN SODIUM
ANDA #214804 |
SUPPL-2 |
HEPARIN SODIUM |
BE PHARMS |
Labeling |
Approval |
| 06/06/2023 |
MESALAMINE
ANDA #217533 |
ORIG-1 |
MESALAMINE |
AMTA |
|
Approval |
| 06/07/2023 |
DROXIA
NDA #016295 |
SUPPL-57 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 06/07/2023 |
HYDREA
NDA #016295 |
SUPPL-57 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 06/07/2023 |
DRAXIMAGE DTPA
NDA #018511 |
SUPPL-32 |
TECHNETIUM TC-99M PENTETATE KIT |
JUBILANT |
Labeling |
Approval |
| 06/07/2023 |
FLUCONAZOLE
ANDA #076658 |
SUPPL-23 |
FLUCONAZOLE |
DR REDDYS LABS INC |
Labeling |
Approval |
| 06/07/2023 |
SERTRALINE HYDROCHLORIDE
ANDA #077977 |
SUPPL-17 |
SERTRALINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 06/07/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090360 |
SUPPL-26 |
BUPRENORPHINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 06/07/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090360 |
SUPPL-27 |
BUPRENORPHINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 06/07/2023 |
NEVIRAPINE
ANDA #090688 |
SUPPL-17 |
NEVIRAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
ABACAVIR SULFATE AND LAMIVUDINE
ANDA #091144 |
SUPPL-18 |
ABACAVIR SULFATE; LAMIVUDINE |
CIPLA |
Labeling |
Approval |
| 06/07/2023 |
ABACAVIR SULFATE AND LAMIVUDINE
ANDA #091144 |
SUPPL-21 |
ABACAVIR SULFATE; LAMIVUDINE |
CIPLA |
Labeling |
Approval |
| 06/07/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422 |
SUPPL-53 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/07/2023 |
PANTOPRAZOLE SODIUM
ANDA #200821 |
SUPPL-26 |
PANTOPRAZOLE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
LEVOFLOXACIN
ANDA #200839 |
SUPPL-30 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
FAMCICLOVIR
ANDA #201022 |
SUPPL-33 |
FAMCICLOVIR |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
DONEPEZIL HYDROCHLORIDE
ANDA #201146 |
SUPPL-22 |
DONEPEZIL HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
AMLODIPINE BESYLATE
ANDA #201380 |
SUPPL-17 |
AMLODIPINE BESYLATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
DONEPEZIL HYDROCHLORIDE
ANDA #201787 |
SUPPL-16 |
DONEPEZIL HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202164 |
SUPPL-22 |
PRAMIPEXOLE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
ESCITALOPRAM OXALATE
ANDA #202210 |
SUPPL-28 |
ESCITALOPRAM OXALATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
LOSARTAN POTASSIUM
ANDA #202230 |
SUPPL-20 |
LOSARTAN POTASSIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #202289 |
SUPPL-28 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
PIOGLITAZONE HYDROCHLORIDE
ANDA #202467 |
SUPPL-23 |
PIOGLITAZONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
VALSARTAN
ANDA #202696 |
SUPPL-25 |
VALSARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
MEMANTINE HYDROCHLORIDE
ANDA #202840 |
SUPPL-21 |
MEMANTINE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
OLANZAPINE
ANDA #202862 |
SUPPL-34 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
OLANZAPINE
ANDA #202862 |
SUPPL-37 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
CLOPIDOGREL BISULFATE
ANDA #202928 |
SUPPL-29 |
CLOPIDOGREL BISULFATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
ESZOPICLONE
ANDA #202929 |
SUPPL-26 |
ESZOPICLONE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
OLANZAPINE
ANDA #203044 |
SUPPL-32 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203145 |
SUPPL-37 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
RIZATRIPTAN BENZOATE
ANDA #203146 |
SUPPL-22 |
RIZATRIPTAN BENZOATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
RIZATRIPTAN BENZOATE
ANDA #203147 |
SUPPL-22 |
RIZATRIPTAN BENZOATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
QUETIAPINE FUMARATE
ANDA #203359 |
SUPPL-21 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
MONTELUKAST SODIUM
ANDA #203366 |
SUPPL-30 |
MONTELUKAST SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
TOLTERODINE TARTRATE
ANDA #203409 |
SUPPL-16 |
TOLTERODINE TARTRATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #203442 |
SUPPL-7 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
RISEDRONATE SODIUM
ANDA #203533 |
SUPPL-20 |
RISEDRONATE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
CANDESARTAN CILEXETIL
ANDA #203813 |
SUPPL-27 |
CANDESARTAN CILEXETIL |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #203824 |
SUPPL-13 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
HIKMA PHARMS |
Labeling |
Approval |
| 06/07/2023 |
ARIPIPRAZOLE
ANDA #204111 |
SUPPL-17 |
ARIPIPRAZOLE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #204169 |
SUPPL-23 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
QUETIAPINE FUMARATE
ANDA #204253 |
SUPPL-21 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #204375 |
SUPPL-25 |
ZIPRASIDONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
CELECOXIB
ANDA #204590 |
SUPPL-21 |
CELECOXIB |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
TAMSULOSIN HYDROCHLORIDE
ANDA #204645 |
SUPPL-16 |
TAMSULOSIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #204802 |
SUPPL-24 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
DULOXETINE HYDROCHLORIDE
ANDA #204815 |
SUPPL-22 |
DULOXETINE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #204889 |
SUPPL-18 |
VENLAFAXINE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
NIACIN
ANDA #204934 |
SUPPL-2 |
NIACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
METFORMIN HYDROCHLORIDE
ANDA #205330 |
SUPPL-11 |
METFORMIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #205702 |
SUPPL-22 |
TRAMADOL HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #206055 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
ZYDUS PHARMS |
|
Approval |
| 06/07/2023 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #206156 |
SUPPL-25 |
PRAMIPEXOLE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #206554 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
NANG KUANG PHARM CO |
|
Approval |
| 06/07/2023 |
NEVIRAPINE
ANDA #206879 |
SUPPL-15 |
NEVIRAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #206885 |
SUPPL-21 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
IBANDRONATE SODIUM
ANDA #206887 |
SUPPL-16 |
IBANDRONATE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
METFORMIN HYDROCHLORIDE
ANDA #206955 |
SUPPL-25 |
METFORMIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
TADALAFIL
ANDA #207290 |
SUPPL-11 |
TADALAFIL |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 06/07/2023 |
VILAZODONE HYDROCHLORIDE
ANDA #208209 |
SUPPL-1 |
VILAZODONE HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 06/07/2023 |
VILAZODONE HYDROCHLORIDE
ANDA #208212 |
SUPPL-3 |
VILAZODONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/07/2023 |
CYCLOPHOSPHAMIDE
NDA #210852 |
ORIG-1 |
CYCLOPHOSPHAMIDE |
DR REDDYS |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 06/07/2023 |
RYALTRIS
NDA #211746 |
SUPPL-3 |
MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE |
GLENMARK SPECIALTY |
Manufacturing (CMC) |
Approval |
| 06/07/2023 |
VEKLURY
NDA #214787 |
SUPPL-23 |
REMDESIVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 06/07/2023 |
MEDROXYPROGESTERONE ACETATE
ANDA #215397 |
ORIG-1 |
MEDROXYPROGESTERONE ACETATE |
AMNEAL |
|
Approval |
| 06/07/2023 |
TICAGRELOR
ANDA #216187 |
ORIG-1 |
TICAGRELOR |
CHANGZHOU PHARM |
|
Tentative Approval |
| 06/07/2023 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #217308 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
MILLA PHARMS |
|
Approval |
| 06/07/2023 |
MELOXICAM
ANDA #217579 |
ORIG-1 |
MELOXICAM |
ASCENT PHARMS INC |
|
Approval |
| 06/08/2023 |
SERTRALINE HYDROCHLORIDE
ANDA #078861 |
SUPPL-21 |
SERTRALINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/08/2023 |
SERTRALINE HYDROCHLORIDE
ANDA #078861 |
SUPPL-23 |
SERTRALINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/08/2023 |
DIVALPROEX SODIUM
ANDA #090070 |
SUPPL-20 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
| 06/08/2023 |
DIVALPROEX SODIUM
ANDA #090070 |
SUPPL-22 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
| 06/08/2023 |
DIVALPROEX SODIUM
ANDA #090070 |
SUPPL-23 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
| 06/08/2023 |
LAMOTRIGINE
ANDA #090170 |
SUPPL-29 |
LAMOTRIGINE |
UNICHEM LABS LTD |
Labeling |
Approval |
| 06/08/2023 |
LAMOTRIGINE
ANDA #090170 |
SUPPL-30 |
LAMOTRIGINE |
UNICHEM LABS LTD |
Labeling |
Approval |
| 06/08/2023 |
LAMOTRIGINE
ANDA #090170 |
SUPPL-34 |
LAMOTRIGINE |
UNICHEM LABS LTD |
Labeling |
Approval |
| 06/08/2023 |
GLYCOPYRROLATE
ANDA #090195 |
SUPPL-4 |
GLYCOPYRROLATE |
LEADING |
Labeling |
Approval |
| 06/08/2023 |
CLOPIDOGREL BISULFATE
ANDA #090540 |
SUPPL-27 |
CLOPIDOGREL BISULFATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 06/08/2023 |
CLOPIDOGREL BISULFATE
ANDA #090540 |
SUPPL-31 |
CLOPIDOGREL BISULFATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 06/08/2023 |
CAPECITABINE
ANDA #200483 |
SUPPL-8 |
CAPECITABINE |
HIKMA |
Labeling |
Approval |
| 06/08/2023 |
MONTELUKAST SODIUM
ANDA #204093 |
SUPPL-1 |
MONTELUKAST SODIUM |
HETERO LABS LTD V |
Labeling |
Approval |
| 06/08/2023 |
MONTELUKAST SODIUM
ANDA #204093 |
SUPPL-3 |
MONTELUKAST SODIUM |
HETERO LABS LTD V |
Labeling |
Approval |
| 06/08/2023 |
MONTELUKAST SODIUM
ANDA #204093 |
SUPPL-5 |
MONTELUKAST SODIUM |
HETERO LABS LTD V |
Labeling |
Approval |
| 06/08/2023 |
MONTELUKAST SODIUM
ANDA #204093 |
SUPPL-7 |
MONTELUKAST SODIUM |
HETERO LABS LTD V |
Labeling |
Approval |
| 06/08/2023 |
MONTELUKAST SODIUM
ANDA #204093 |
SUPPL-13 |
MONTELUKAST SODIUM |
HETERO LABS LTD V |
Labeling |
Approval |
| 06/08/2023 |
TELMISARTAN
ANDA #207016 |
SUPPL-10 |
TELMISARTAN |
MICRO LABS |
Labeling |
Approval |
| 06/08/2023 |
AZACITIDINE
NDA #208216 |
SUPPL-6 |
AZACITIDINE |
ACTAVIS LLC |
Labeling |
Approval |
| 06/08/2023 |
DIVALPROEX SODIUM
ANDA #214462 |
SUPPL-1 |
DIVALPROEX SODIUM |
AMTA |
Labeling |
Approval |
| 06/08/2023 |
BACLOFEN
ANDA #217252 |
ORIG-1 |
BACLOFEN |
ANI PHARMS |
|
Approval |
| 06/08/2023 |
BALSALAZIDE DISODIUM
ANDA #217592 |
ORIG-1 |
BALSALAZIDE DISODIUM |
ZYDUS LIFESCIENCES |
|
Approval |
| 06/09/2023 |
FURADANTIN
NDA #009175 |
SUPPL-49 |
NITROFURANTOIN |
CASPER PHARMA LLC |
Manufacturing (CMC) |
Approval |
| 06/09/2023 |
DIVALPROEX SODIUM
ANDA #090161 |
SUPPL-20 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 06/09/2023 |
DIVALPROEX SODIUM
ANDA #090161 |
SUPPL-22 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 06/09/2023 |
DIVALPROEX SODIUM
ANDA #090161 |
SUPPL-23 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #091025 |
SUPPL-4 |
PREGABALIN |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/09/2023 |
ENBREL
BLA #103795 |
SUPPL-5594 |
ETANERCEPT |
IMMUNEX |
|
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #203459 |
SUPPL-4 |
PREGABALIN |
ALEMBIC |
Labeling |
Approval |
| 06/09/2023 |
ATORVASTATIN CALCIUM
ANDA #204991 |
SUPPL-14 |
ATORVASTATIN CALCIUM |
LUPIN LTD |
Labeling |
Approval |
| 06/09/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022 |
SUPPL-18 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
| 06/09/2023 |
TELMISARTAN
ANDA #206511 |
SUPPL-11 |
TELMISARTAN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/09/2023 |
TELMISARTAN
ANDA #206511 |
SUPPL-13 |
TELMISARTAN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/09/2023 |
TELMISARTAN
ANDA #206511 |
SUPPL-14 |
TELMISARTAN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 06/09/2023 |
ATORVASTATIN CALCIUM
ANDA #207687 |
SUPPL-13 |
ATORVASTATIN CALCIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 06/09/2023 |
DICLOFENAC SODIUM
ANDA #208301 |
SUPPL-3 |
DICLOFENAC SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 06/09/2023 |
DICLOFENAC SODIUM
ANDA #208301 |
SUPPL-4 |
DICLOFENAC SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 06/09/2023 |
DICLOFENAC SODIUM
ANDA #208301 |
SUPPL-5 |
DICLOFENAC SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 06/09/2023 |
IMATINIB MESYLATE
ANDA #208302 |
SUPPL-2 |
IMATINIB MESYLATE |
SHILPA |
Labeling |
Approval |
| 06/09/2023 |
IMATINIB MESYLATE
ANDA #208302 |
SUPPL-6 |
IMATINIB MESYLATE |
SHILPA |
Labeling |
Approval |
| 06/09/2023 |
IMATINIB MESYLATE
ANDA #208302 |
SUPPL-7 |
IMATINIB MESYLATE |
SHILPA |
Labeling |
Approval |
| 06/09/2023 |
ATORVASTATIN CALCIUM
ANDA #209288 |
SUPPL-14 |
ATORVASTATIN CALCIUM |
ALKEM LABS LTD |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #209357 |
SUPPL-1 |
PREGABALIN |
MSN |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #209357 |
SUPPL-6 |
PREGABALIN |
MSN |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #209664 |
SUPPL-2 |
PREGABALIN |
DR REDDYS |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #209743 |
SUPPL-5 |
PREGABALIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #209743 |
SUPPL-14 |
PREGABALIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #209743 |
SUPPL-17 |
PREGABALIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #210432 |
SUPPL-3 |
PREGABALIN |
RISING |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #211384 |
SUPPL-4 |
PREGABALIN |
INVAGEN PHARMS |
Labeling |
Approval |
| 06/09/2023 |
LURASIDONE HYDROCHLORIDE
ANDA #212124 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
|
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #212280 |
SUPPL-2 |
PREGABALIN |
CIPLA |
Labeling |
Approval |
| 06/09/2023 |
PREGABALIN
ANDA #212280 |
SUPPL-6 |
PREGABALIN |
CIPLA |
Labeling |
Approval |
| 06/09/2023 |
PIRFENIDONE
ANDA #212687 |
ORIG-1 |
PIRFENIDONE |
APOTEX |
|
Approval |
| 06/09/2023 |
SUGAMMADEX SODIUM
ANDA #214337 |
ORIG-1 |
SUGAMMADEX SODIUM |
ASPIRO |
|
Approval |
| 06/09/2023 |
DIVALPROEX SODIUM
ANDA #214643 |
SUPPL-2 |
DIVALPROEX SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/09/2023 |
CIPROFLOXACIN AND DEXAMETHASONE
ANDA #215768 |
ORIG-1 |
CIPROFLOXACIN; DEXAMETHASONE |
SENTISS |
|
Approval |
| 06/09/2023 |
CISATRACURIUM BESYLATE
ANDA #217725 |
ORIG-1 |
CISATRACURIUM BESYLATE |
CAPLIN |
|
Approval |
| 06/12/2023 |
ENTEREG
NDA #021775 |
SUPPL-20 |
ALVIMOPAN |
CUBIST PHARMS |
REMS |
Approval |
| 06/12/2023 |
LINZESS
NDA #202811 |
SUPPL-21 |
LINACLOTIDE |
ABBVIE |
Efficacy |
Approval |
| 06/12/2023 |
ARIPIPRAZOLE
ANDA #203025 |
SUPPL-3 |
ARIPIPRAZOLE |
UNICHEM |
Labeling |
Approval |
| 06/12/2023 |
DESIPRAMINE HYDROCHLORIDE
ANDA #204963 |
SUPPL-4 |
DESIPRAMINE HYDROCHLORIDE |
NOVAST LABS |
Labeling |
Approval |
| 06/12/2023 |
COLISTIMETHATE SODIUM
ANDA #205356 |
SUPPL-1 |
COLISTIMETHATE SODIUM |
XELLIA PHARMS APS |
Labeling |
Approval |
| 06/12/2023 |
COLISTIMETHATE SODIUM
ANDA #205356 |
SUPPL-4 |
COLISTIMETHATE SODIUM |
XELLIA PHARMS APS |
Labeling |
Approval |
| 06/12/2023 |
ADEFOVIR DIPIVOXIL
ANDA #205459 |
SUPPL-2 |
ADEFOVIR DIPIVOXIL |
APOTEX |
Labeling |
Approval |
| 06/12/2023 |
PRIMAQUINE PHOSPHATE
ANDA #206043 |
SUPPL-1 |
PRIMAQUINE PHOSPHATE |
NOVAST LABS |
Labeling |
Approval |
| 06/12/2023 |
PRIMAQUINE PHOSPHATE
ANDA #206043 |
SUPPL-2 |
PRIMAQUINE PHOSPHATE |
NOVAST LABS |
Labeling |
Approval |
| 06/12/2023 |
OLANZAPINE
ANDA #206155 |
SUPPL-2 |
OLANZAPINE |
INDOCO |
Labeling |
Approval |
| 06/12/2023 |
CYTARABINE
ANDA #206190 |
SUPPL-1 |
CYTARABINE |
MEITHEAL |
Labeling |
Approval |
| 06/12/2023 |
DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #206771 |
ORIG-1 |
DICLOFENAC SODIUM; MISOPROSTOL |
ZYDUS PHARMS |
|
Approval |
| 06/12/2023 |
NAFTIFINE HYDROCHLORIDE
ANDA #206960 |
SUPPL-4 |
NAFTIFINE HYDROCHLORIDE |
AMNEAL |
Labeling |
Approval |
| 06/12/2023 |
OMEPRAZOLE
ANDA #207891 |
SUPPL-7 |
OMEPRAZOLE |
SUN PHARM |
Labeling |
Approval |
| 06/12/2023 |
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
ANDA #208111 |
SUPPL-5 |
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
| 06/12/2023 |
ALVIMOPAN
ANDA #208295 |
SUPPL-4 |
ALVIMOPAN |
WATSON LABS TEVA |
REMS |
Approval |
| 06/12/2023 |
EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #212339 |
ORIG-1 |
EMPAGLIFLOZIN;LINAGLIPTIN |
SUN PHARM INDS INC |
|
Tentative Approval |
| 06/12/2023 |
METHOCARBAMOL
ANDA #212707 |
ORIG-1 |
METHOCARBAMOL |
MIKART |
|
Approval |
| 06/12/2023 |
VEKLURY
NDA #214787 |
SUPPL-21 |
REMDESIVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 06/12/2023 |
VARENICLINE TARTRATE
ANDA #216723 |
ORIG-1 |
VARENICLINE TARTRATE |
ZYDUS |
|
Approval |
| 06/12/2023 |
ALVIMOPAN
ANDA #216843 |
SUPPL-1 |
ALVIMOPAN |
PAR PHARM |
REMS |
Approval |
| 06/12/2023 |
METOPROLOL SUCCINATE
ANDA #216916 |
ORIG-1 |
METOPROLOL SUCCINATE |
GRANULES |
|
Approval |
| 06/13/2023 |
OLANZAPINE
ANDA #078109 |
SUPPL-13 |
OLANZAPINE |
STRIDES PHARMA |
Labeling |
Approval |
| 06/13/2023 |
OLANZAPINE
ANDA #090798 |
SUPPL-4 |
OLANZAPINE |
APOTEX INC |
Labeling |
Approval |
| 06/13/2023 |
OLANZAPINE
ANDA #090798 |
SUPPL-6 |
OLANZAPINE |
APOTEX INC |
Labeling |
Approval |
| 06/13/2023 |
OLANZAPINE
ANDA #090798 |
SUPPL-10 |
OLANZAPINE |
APOTEX INC |
Labeling |
Approval |
| 06/13/2023 |
OLANZAPINE
ANDA #090798 |
SUPPL-12 |
OLANZAPINE |
APOTEX INC |
Labeling |
Approval |
| 06/13/2023 |
OLANZAPINE
ANDA #090798 |
SUPPL-14 |
OLANZAPINE |
APOTEX INC |
Labeling |
Approval |
| 06/13/2023 |
OLANZAPINE
ANDA #090798 |
SUPPL-18 |
OLANZAPINE |
APOTEX INC |
Labeling |
Approval |
| 06/13/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #209069 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
WES PHARMA INC |
Labeling |
Approval |
| 06/13/2023 |
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE
ANDA #214008 |
ORIG-1 |
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE |
NATCO |
|
Approval |
| 06/13/2023 |
AMLODIPINE BENZOATE
ANDA #215035 |
ORIG-1 |
AMLODIPINE BENZOATE |
AMNEAL |
|
Approval |
| 06/13/2023 |
BYLVAY
NDA #215498 |
SUPPL-3 |
ODEVIXIBAT |
IPSEN |
Efficacy |
Approval |
| 06/13/2023 |
OCTREOTIDE ACETATE
ANDA #216807 |
ORIG-1 |
OCTREOTIDE ACETATE |
GLAND PHARMA LTD |
|
Approval |
| 06/13/2023 |
LEVETIRACETAM
ANDA #217878 |
ORIG-1 |
LEVETIRACETAM |
GRANULES |
|
Approval |
| 06/14/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090819 |
SUPPL-27 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/14/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090819 |
SUPPL-30 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/14/2023 |
ADCETRIS
BLA #125388 |
SUPPL-107 |
BRENTUXIMAB VEDOTIN |
SEATTLE GENETICS |
|
Approval |
| 06/14/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000 |
SUPPL-25 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 06/14/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000 |
SUPPL-30 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 06/14/2023 |
SAFINAMIDE MESYLATE
ANDA #215902 |
ORIG-1 |
SAFINAMIDE MESYLATE |
AUROBINDO PHARMA |
|
Approval |
| 06/14/2023 |
MOMETASONE FUROATE
ANDA #217460 |
ORIG-1 |
MOMETASONE FUROATE |
AMNEAL |
|
Approval |
| 06/14/2023 |
ABRILADA
BLA #761118 |
SUPPL-9 |
ADALIMUMAB-AFZB |
PFIZER INC |
|
Approval |
| 06/14/2023 |
IMJUDO
BLA #761289 |
SUPPL-2 |
TREMELIMUMAB-ACTL |
ASTRAZENECA AB |
|
Approval |
| 06/15/2023 |
BREVIBLOC
NDA #019386 |
SUPPL-53 |
ESMOLOL HYDROCHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
NDA #019386 |
SUPPL-53 |
ESMOLOL HYDROCHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
BREVIBLOC IN PLASTIC CONTAINER
NDA #019386 |
SUPPL-53 |
ESMOLOL HYDROCHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
ORTHO TRI-CYCLEN
NDA #019697 |
SUPPL-56 |
ETHINYL ESTRADIOL; NORGESTIMATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 06/15/2023 |
ORTHO TRI-CYCLEN
NDA #019697 |
SUPPL-57 |
ETHINYL ESTRADIOL; NORGESTIMATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 06/15/2023 |
BETAPACE
NDA #019865 |
SUPPL-26 |
SOTALOL HYDROCHLORIDE |
LEGACY PHARMA |
Labeling |
Approval |
| 06/15/2023 |
ULTRAVIST 150
NDA #020220 |
SUPPL-55 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
ULTRAVIST 240
NDA #020220 |
SUPPL-55 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
ULTRAVIST 300
NDA #020220 |
SUPPL-55 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220 |
SUPPL-55 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
ULTRAVIST 370
NDA #020220 |
SUPPL-55 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
ULTRAVIST (PHARMACY BULK)
NDA #021425 |
SUPPL-37 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 06/15/2023 |
TRIUMEQ
NDA #205551 |
SUPPL-31 |
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 06/15/2023 |
ARIPIPRAZOLE
ANDA #206174 |
SUPPL-2 |
ARIPIPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 06/15/2023 |
ARIPIPRAZOLE
ANDA #206174 |
SUPPL-10 |
ARIPIPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 06/15/2023 |
ARIPIPRAZOLE
ANDA #206174 |
SUPPL-12 |
ARIPIPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 06/15/2023 |
ARIPIPRAZOLE
ANDA #206174 |
SUPPL-34 |
ARIPIPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 06/15/2023 |
CYTARABINE
ANDA #206189 |
SUPPL-1 |
CYTARABINE |
MEITHEAL |
Labeling |
Approval |
| 06/15/2023 |
REMIFENTANIL HYDROCHLORIDE
ANDA #206223 |
SUPPL-1 |
REMIFENTANIL HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/15/2023 |
REMIFENTANIL HYDROCHLORIDE
ANDA #206223 |
SUPPL-2 |
REMIFENTANIL HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/15/2023 |
XOFLUZA
NDA #210854 |
SUPPL-18 |
BALOXAVIR MARBOXIL |
GENENTECH INC |
Labeling |
Approval |
| 06/15/2023 |
LABETALOL HYDROCHLORIDE
NDA #213330 |
SUPPL-5 |
LABETALOL HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 06/15/2023 |
LABETALOL HYDROCHLORIDE IN DEXTROSE
NDA #213330 |
SUPPL-5 |
LABETALOL HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 06/15/2023 |
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
NDA #213330 |
SUPPL-5 |
LABETALOL HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 06/15/2023 |
XOFLUZA
NDA #214410 |
SUPPL-5 |
BALOXAVIR MARBOXIL |
GENENTECH INC |
Labeling |
Approval |
| 06/15/2023 |
CAMZYOS
NDA #214998 |
SUPPL-1 |
MAVACAMTEN |
BRISTOL |
Efficacy |
Approval |
| 06/15/2023 |
SUFLAVE
NDA #215344 |
ORIG-1 |
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE |
BRAINTREE LABS |
Type 4 - New Combination |
Approval |
| 06/15/2023 |
TRIUMEQ PD
NDA #215413 |
SUPPL-2 |
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 06/15/2023 |
DOXERCALCIFEROL
ANDA #215810 |
ORIG-1 |
DOXERCALCIFEROL |
ALEMBIC |
|
Approval |
| 06/15/2023 |
SODIUM BICARBONATE
ANDA #216364 |
ORIG-1 |
SODIUM BICARBONATE |
OMNIVIUM PHARMS |
|
Approval |
| 06/15/2023 |
CARBOPROST TROMETHAMINE
ANDA #217198 |
ORIG-1 |
CARBOPROST TROMETHAMINE |
ALEMBIC |
|
Approval |
| 06/15/2023 |
COLUMVI
BLA #761309 |
ORIG-1 |
GLOFITAMAB-GXBM |
GENENTECH INC |
|
Approval |
| 06/16/2023 |
BYSTOLIC
NDA #021742 |
SUPPL-28 |
NEBIVOLOL HYDROCHLORIDE |
ALLERGAN |
Labeling |
Approval |
| 06/16/2023 |
CARBOPLATIN
ANDA #077861 |
SUPPL-2 |
CARBOPLATIN |
TEYRO LABS |
Manufacturing (CMC) |
Approval |
| 06/16/2023 |
LEVETIRACETAM
ANDA #091399 |
SUPPL-25 |
LEVETIRACETAM |
LUPIN LTD |
Labeling |
Approval |
| 06/16/2023 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963 |
SUPPL-6 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/16/2023 |
MINOCYCLINE HYDROCHLORIDE
ANDA #203553 |
ORIG-2 |
MINOCYCLINE HYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
| 06/16/2023 |
BYVALSON
NDA #206302 |
SUPPL-1 |
NEBIVOLOL HYDROCHLORIDE; VALSARTAN |
ABBVIE |
Labeling |
Approval |
| 06/16/2023 |
ROZLYTREK
NDA #212725 |
SUPPL-7 |
ENTRECTINIB |
GENENTECH INC |
Labeling |
Approval |
| 06/16/2023 |
METRONIDAZOLE
ANDA #215610 |
ORIG-1 |
METRONIDAZOLE |
ENCUBE |
|
Approval |
| 06/16/2023 |
LODOCO
NDA #215727 |
ORIG-1 |
COLCHICINE |
AGEPHA PHARMA FZ |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 06/16/2023 |
PANTOPRAZOLE SODIUM
ANDA #216247 |
ORIG-1 |
PANTOPRAZOLE SODIUM |
DEXCEL |
|
Approval |
| 06/16/2023 |
POTASSIUM CHLORIDE
ANDA #216321 |
ORIG-1 |
POTASSIUM CHLORIDE |
RUBICON |
|
Approval |
| 06/16/2023 |
RUFINAMIDE
ANDA #217230 |
ORIG-1 |
RUFINAMIDE |
AUROBINDO PHARMA |
|
Approval |
| 06/16/2023 |
FAMOTIDINE
ANDA #217655 |
ORIG-1 |
FAMOTIDINE |
UPSHER SMITH LABS |
|
Approval |
| 06/16/2023 |
LIDOCAINE HYDROCHLORIDE
ANDA #217692 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
MANKIND PHARMA |
|
Approval |
| 06/16/2023 |
IMFINZI
BLA #761069 |
SUPPL-42 |
DURVALUMAB |
ASTRAZENECA UK LTD |
|
Approval |
| 06/16/2023 |
ROLVEDON
BLA #761148 |
SUPPL-2 |
EFLAPEGRASTIM-XNST |
SPECTRUM PHARMS |
|
Approval |
| 06/16/2023 |
BYOOVIZ
BLA #761202 |
SUPPL-7 |
RANIBIZUMAB-NUNA |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
| 06/17/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090360 |
SUPPL-21 |
BUPRENORPHINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 06/17/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090360 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 06/20/2023 |
MIRALAX
NDA #022015 |
SUPPL-46 |
POLYETHYLENE GLYCOL 3350 |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 06/20/2023 |
ROCURONIUM BROMIDE
ANDA #079195 |
SUPPL-22 |
ROCURONIUM BROMIDE |
SANDOZ |
Labeling |
Approval |
| 06/20/2023 |
BLINCYTO
BLA #125557 |
SUPPL-23 |
BLINATUMOMAB |
AMGEN |
|
Approval |
| 06/20/2023 |
BLINCYTO
BLA #125557 |
SUPPL-26 |
BLINATUMOMAB |
AMGEN |
|
Approval |
| 06/20/2023 |
TRADJENTA
NDA #201280 |
SUPPL-27 |
LINAGLIPTIN |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 06/20/2023 |
JENTADUETO
NDA #201281 |
SUPPL-35 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 06/20/2023 |
PHENOXYBENZAMINE HYDROCHLORIDE
ANDA #204551 |
ORIG-1 |
PHENOXYBENZAMINE HYDROCHLORIDE |
RISING |
|
Approval |
| 06/20/2023 |
JARDIANCE
NDA #204629 |
SUPPL-42 |
EMPAGLIFLOZIN |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 06/20/2023 |
SYNJARDY
NDA #206111 |
SUPPL-38 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 06/20/2023 |
SYNJARDY
NDA #206111 |
SUPPL-39 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 06/20/2023 |
JENTADUETO XR
NDA #208026 |
SUPPL-24 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 06/20/2023 |
GALAFOLD
NDA #208623 |
SUPPL-6 |
MIGALASTAT HYDROCHLORIDE |
AMICUS THERAP US |
Labeling |
Approval |
| 06/20/2023 |
GALAFOLD
NDA #208623 |
SUPPL-7 |
MIGALASTAT HYDROCHLORIDE |
AMICUS THERAP US |
Labeling |
Approval |
| 06/20/2023 |
SYNJARDY XR
NDA #208658 |
SUPPL-25 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 06/20/2023 |
SYNJARDY XR
NDA #208658 |
SUPPL-26 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 06/20/2023 |
TIOTROPIUM BROMIDE
ANDA #211287 |
ORIG-1 |
TIOTROPIUM BROMIDE |
LUPIN |
|
Approval |
| 06/20/2023 |
TALZENNA
NDA #211651 |
SUPPL-10 |
TALAZOPARIB TOSYLATE |
PFIZER |
Efficacy |
Approval |
| 06/20/2023 |
METFORMIN HYDROCHLORIDE
ANDA #215629 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
RK PHARMA |
|
Approval |
| 06/20/2023 |
POSACONAZOLE
ANDA #216326 |
ORIG-1 |
POSACONAZOLE |
WESTMINSTER PHARMS |
|
Approval |
| 06/20/2023 |
KETOROLAC TROMETHAMINE
ANDA #217166 |
ORIG-1 |
KETOROLAC TROMETHAMINE |
ASPIRO |
|
Approval |
| 06/20/2023 |
TOPIRAMATE
ANDA #217248 |
ORIG-1 |
TOPIRAMATE |
ALKEM LABS LTD |
|
Approval |
| 06/20/2023 |
VYVGART HYTRULO
BLA #761304 |
ORIG-1 |
EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC |
ARGENX BV |
|
Approval |
| 06/20/2023 |
Hyaluronidase human recombinant for further manufacturing use
BLA #761313 |
ORIG-1 |
Hyaluronidase human recombinant for further manufacturing use |
HALOZYME THERAP |
|
Approval |
| 06/21/2023 |
TEMAZEPAM
ANDA #071427 |
SUPPL-34 |
TEMAZEPAM |
CHARTWELL RX |
Labeling |
Approval |
| 06/21/2023 |
TEMAZEPAM
ANDA #071428 |
SUPPL-34 |
TEMAZEPAM |
CHARTWELL RX |
Labeling |
Approval |
| 06/21/2023 |
MODAFINIL
ANDA #077667 |
SUPPL-10 |
MODAFINIL |
APOTEX |
Labeling |
Approval |
| 06/21/2023 |
BUPROPION HYDROCHLORIDE
ANDA #078866 |
SUPPL-13 |
BUPROPION HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 06/21/2023 |
BUPROPION HYDROCHLORIDE
ANDA #078866 |
SUPPL-14 |
BUPROPION HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 06/21/2023 |
BUPROPION HYDROCHLORIDE
ANDA #078866 |
SUPPL-21 |
BUPROPION HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 06/21/2023 |
BUPROPION HYDROCHLORIDE
ANDA #078866 |
SUPPL-24 |
BUPROPION HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 06/21/2023 |
ABACAVIR SULFATE AND LAMIVUDINE
ANDA #079246 |
SUPPL-11 |
ABACAVIR SULFATE; LAMIVUDINE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/21/2023 |
LEVOFLOXACIN
ANDA #090722 |
SUPPL-15 |
LEVOFLOXACIN |
TORRENT PHARMS |
Labeling |
Approval |
| 06/21/2023 |
PREGABALIN
ANDA #207799 |
SUPPL-1 |
PREGABALIN |
ALKEM LABS LTD |
Labeling |
Approval |
| 06/21/2023 |
PREGABALIN
ANDA #207799 |
SUPPL-7 |
PREGABALIN |
ALKEM LABS LTD |
Labeling |
Approval |
| 06/21/2023 |
TAGRISSO
NDA #208065 |
SUPPL-28 |
OSIMERTINIB MESYLATE |
ASTRAZENECA |
Labeling |
Approval |
| 06/21/2023 |
FIASP
BLA #208751 |
SUPPL-20 |
INSULIN ASPART |
NOVO |
|
Approval |
| 06/21/2023 |
FIASP FLEXTOUCH
BLA #208751 |
SUPPL-20 |
INSULIN ASPART |
NOVO |
|
Approval |
| 06/21/2023 |
FIASP PENFILL
BLA #208751 |
SUPPL-20 |
INSULIN ASPART |
NOVO |
|
Approval |
| 06/21/2023 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #209609 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 06/21/2023 |
FINZALA
ANDA #210087 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA PHARMS USA INC |
Labeling |
Approval |
| 06/21/2023 |
FENOFIBRIC ACID
ANDA #211626 |
SUPPL-2 |
CHOLINE FENOFIBRATE |
GRAVITI PHARMS |
Labeling |
Approval |
| 06/21/2023 |
ZTALMY
NDA #215904 |
SUPPL-3 |
GANAXOLONE |
MARINUS |
Labeling |
Approval |
| 06/21/2023 |
ZTALMY
NDA #215904 |
SUPPL-4 |
GANAXOLONE |
MARINUS |
Labeling |
Approval |
| 06/21/2023 |
TOLVAPTAN
ANDA #216949 |
ORIG-1 |
TOLVAPTAN |
MSN |
|
Approval |
| 06/21/2023 |
TOBRAMYCIN SULFATE
ANDA #217519 |
ORIG-1 |
TOBRAMYCIN SULFATE |
EUGIA PHARMA |
|
Approval |
| 06/22/2023 |
HIBICLENS
NDA #017768 |
SUPPL-60 |
CHLORHEXIDINE GLUCONATE |
MOLNLYCKE HLTH |
Manufacturing (CMC) |
Approval |
| 06/22/2023 |
LEVOBUNOLOL HYDROCHLORIDE
ANDA #074326 |
SUPPL-33 |
LEVOBUNOLOL HYDROCHLORIDE |
BAUSCH AND LOMB |
Labeling |
Approval |
| 06/22/2023 |
LEVOBUNOLOL HYDROCHLORIDE
ANDA #074326 |
SUPPL-38 |
LEVOBUNOLOL HYDROCHLORIDE |
BAUSCH AND LOMB |
Labeling |
Approval |
| 06/22/2023 |
EVEROLIMUS
ANDA #205426 |
SUPPL-3 |
EVEROLIMUS |
BRECKENRIDGE |
Labeling |
Approval |
| 06/22/2023 |
EVEROLIMUS
ANDA #205426 |
SUPPL-4 |
EVEROLIMUS |
BRECKENRIDGE |
Labeling |
Approval |
| 06/22/2023 |
EVEROLIMUS
ANDA #205426 |
SUPPL-9 |
EVEROLIMUS |
BRECKENRIDGE |
Manufacturing (CMC) |
Approval |
| 06/22/2023 |
MIBELAS 24 FE
ANDA #206287 |
SUPPL-18 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN |
Labeling |
Approval |
| 06/22/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #207276 |
SUPPL-16 |
BUPRENORPHINE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
| 06/22/2023 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #207514 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/22/2023 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #207514 |
SUPPL-13 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/22/2023 |
AMPHETAMINE
ANDA #209253 |
ORIG-1 |
AMPHETAMINE |
ACTAVIS LABS FL INC |
|
Approval |
| 06/22/2023 |
RINVOQ
NDA #211675 |
SUPPL-17 |
UPADACITINIB |
ABBVIE |
Efficacy |
Approval |
| 06/22/2023 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #212130 |
SUPPL-4 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MEITHEAL |
Labeling |
Approval |
| 06/22/2023 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #212130 |
SUPPL-5 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MEITHEAL |
Labeling |
Approval |
| 06/22/2023 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #216390 |
SUPPL-2 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
STERISCIENCE |
Labeling |
Approval |
| 06/22/2023 |
OCTREOTIDE ACETATE
ANDA #216839 |
ORIG-1 |
OCTREOTIDE ACETATE |
GLAND PHARMA LTD |
|
Approval |
| 06/22/2023 |
DIHYDROERGOTAMINE MESYLATE
ANDA #216881 |
ORIG-1 |
DIHYDROERGOTAMINE MESYLATE |
RUBICON |
|
Approval |
| 06/23/2023 |
ELOXATIN
NDA #021759 |
SUPPL-24 |
OXALIPLATIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 06/23/2023 |
SPIRONOLACTONE
ANDA #040750 |
SUPPL-29 |
SPIRONOLACTONE |
OXFORD PHARMS |
Labeling |
Approval |
| 06/23/2023 |
GLYCOPYRROLATE
ANDA #040836 |
SUPPL-4 |
GLYCOPYRROLATE |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 06/23/2023 |
HALOPERIDOL
ANDA #075858 |
SUPPL-23 |
HALOPERIDOL LACTATE |
HIKMA |
Labeling |
Approval |
| 06/23/2023 |
KETAMINE HYDROCHLORIDE
ANDA #076092 |
SUPPL-29 |
KETAMINE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 06/23/2023 |
MYORISAN
ANDA #076485 |
SUPPL-38 |
ISOTRETINOIN |
UPSHER SMITH LABS |
REMS |
Approval |
| 06/23/2023 |
ALPRAZOLAM
ANDA #078056 |
SUPPL-18 |
ALPRAZOLAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/23/2023 |
ALPRAZOLAM
ANDA #078056 |
SUPPL-20 |
ALPRAZOLAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/23/2023 |
ALPRAZOLAM
ANDA #078056 |
SUPPL-21 |
ALPRAZOLAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 06/23/2023 |
IBANDRONATE SODIUM
ANDA #078948 |
SUPPL-8 |
IBANDRONATE SODIUM |
APOTEX INC |
Labeling |
Approval |
| 06/23/2023 |
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
ANDA #090019 |
SUPPL-15 |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 06/23/2023 |
ADCETRIS
BLA #125388 |
SUPPL-104 |
BRENTUXIMAB VEDOTIN |
SEATTLE GENETICS |
|
Approval |
| 06/23/2023 |
HALOPERIDOL
ANDA #204849 |
SUPPL-3 |
HALOPERIDOL LACTATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 06/23/2023 |
AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #207216 |
SUPPL-17 |
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 06/23/2023 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #207884 |
SUPPL-3 |
METHYLPHENIDATE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 06/23/2023 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #207884 |
SUPPL-4 |
METHYLPHENIDATE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 06/23/2023 |
AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #209042 |
SUPPL-5 |
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL |
ALKEM LABS LTD |
Labeling |
Approval |
| 06/23/2023 |
ALCAFTADINE
ANDA #210659 |
ORIG-1 |
ALCAFTADINE |
EUGIA PHARMA |
|
Approval |
| 06/23/2023 |
DEFERASIROX
ANDA #211383 |
SUPPL-2 |
DEFERASIROX |
ZYDUS PHARMS |
Labeling |
Approval |
| 06/23/2023 |
DEFERASIROX
ANDA #211383 |
SUPPL-3 |
DEFERASIROX |
ZYDUS PHARMS |
Labeling |
Approval |
| 06/23/2023 |
DEFERASIROX
ANDA #211383 |
SUPPL-4 |
DEFERASIROX |
ZYDUS PHARMS |
Labeling |
Approval |
| 06/23/2023 |
VORICONAZOLE
ANDA #211661 |
SUPPL-10 |
VORICONAZOLE |
SLATE RUN PHARMA |
Labeling |
Approval |
| 06/23/2023 |
ALBUTEROL SULFATE
ANDA #211888 |
SUPPL-1 |
ALBUTEROL SULFATE |
LUOXIN AUROVITAS |
Labeling |
Approval |
| 06/23/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #215338 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
AMNEAL |
|
Approval |
| 06/23/2023 |
LITFULO
NDA #215830 |
ORIG-1 |
RITLECITINIB TOSYLATE |
PFIZER |
Type 1 - New Molecular Entity |
Approval |
| 06/23/2023 |
BUPIVACAINE HYDROCHLORIDE
ANDA #216039 |
ORIG-1 |
BUPIVACAINE HYDROCHLORIDE |
KINDOS |
|
Approval |
| 06/26/2023 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
NDA #022573 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 06/26/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090279 |
SUPPL-18 |
BUPRENORPHINE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
| 06/26/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090279 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
| 06/26/2023 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090622 |
SUPPL-41 |
BUPRENORPHINE HYDROCHLORIDE |
ETHYPHARM |
Labeling |
Approval |
| 06/26/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/26/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/26/2023 |
MONTELUKAST SODIUM
ANDA #200405 |
SUPPL-16 |
MONTELUKAST SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 06/26/2023 |
MONTELUKAST SODIUM
ANDA #200405 |
SUPPL-17 |
MONTELUKAST SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 06/26/2023 |
MINASTRIN 24 FE
NDA #203667 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
| 06/26/2023 |
TAYTULLA
NDA #204426 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
| 06/26/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431 |
SUPPL-32 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ETHYPHARM USA CORP |
Labeling |
Approval |
| 06/26/2023 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205601 |
SUPPL-16 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
| 06/26/2023 |
PREGABALIN
ANDA #207623 |
SUPPL-1 |
PREGABALIN |
ALKEM LABS LTD |
Labeling |
Approval |
| 06/26/2023 |
TELMISARTAN
ANDA #207882 |
SUPPL-9 |
TELMISARTAN |
PRINSTON INC |
Labeling |
Approval |
| 06/26/2023 |
SCEMBLIX
NDA #215358 |
SUPPL-3 |
ASCIMINIB HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 06/26/2023 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #217521 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
BE PHARMS |
|
Approval |
| 06/26/2023 |
HADLIMA
BLA #761059 |
SUPPL-6 |
ADALIMUMAB-BWWD |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
| 06/26/2023 |
RYSTIGGO
BLA #761286 |
ORIG-1 |
ROZANOLIXIZUMAB-NOLI |
UCB INC |
|
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630 |
SUPPL-53 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 06/27/2023 |
TRANEXAMIC ACID
ANDA #202436 |
SUPPL-7 |
TRANEXAMIC ACID |
ACIC PHARMS |
Labeling |
Approval |
| 06/27/2023 |
AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #202933 |
SUPPL-13 |
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL |
TORRENT |
Labeling |
Approval |
| 06/27/2023 |
HALOPERIDOL
ANDA #210356 |
SUPPL-2 |
HALOPERIDOL LACTATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/27/2023 |
PALBOCICLIB
ANDA #216339 |
ORIG-1 |
PALBOCICLIB |
ZYDUS WORLDWIDE DMCC |
|
Tentative Approval |
| 06/27/2023 |
CYCLOPHOSPHAMIDE
NDA #217651 |
ORIG-1 |
CYCLOPHOSPHAMIDE |
BAXTER HLTHCARE CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 06/27/2023 |
DOXEPIN HYDROCHLORIDE
ANDA #217688 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
MICRO LABS |
|
Approval |
| 06/27/2023 |
NGENLA
BLA #761184 |
ORIG-1 |
SOMATROGON-GHLA |
PFIZER IRELAND PHARMACEUTICALS |
|
Approval |
| 06/28/2023 |
AZOPT
NDA #020816 |
SUPPL-25 |
BRINZOLAMIDE |
SANDOZ |
Labeling |
Approval |
| 06/28/2023 |
QSYMIA
NDA #022580 |
SUPPL-23 |
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE |
VIVUS |
Labeling |
Approval |
| 06/28/2023 |
TRIAZOLAM
ANDA #074224 |
SUPPL-12 |
TRIAZOLAM |
HIKMA |
Labeling |
Approval |
| 06/28/2023 |
KETOROLAC TROMETHAMINE
ANDA #075626 |
SUPPL-14 |
KETOROLAC TROMETHAMINE |
APOTEX INC |
Labeling |
Approval |
| 06/28/2023 |
KETOROLAC TROMETHAMINE
ANDA #075626 |
SUPPL-15 |
KETOROLAC TROMETHAMINE |
APOTEX INC |
Labeling |
Approval |
| 06/28/2023 |
PAROXETINE HYDROCHLORIDE
ANDA #076968 |
SUPPL-1 |
PAROXETINE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 06/28/2023 |
PAROXETINE HYDROCHLORIDE
ANDA #076968 |
SUPPL-4 |
PAROXETINE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 06/28/2023 |
KETOROLAC TROMETHAMINE
ANDA #077201 |
SUPPL-5 |
KETOROLAC TROMETHAMINE |
APOTEX INC |
Labeling |
Approval |
| 06/28/2023 |
KETOROLAC TROMETHAMINE
ANDA #077201 |
SUPPL-6 |
KETOROLAC TROMETHAMINE |
APOTEX INC |
Labeling |
Approval |
| 06/28/2023 |
MOMETASONE FUROATE
ANDA #077401 |
SUPPL-6 |
MOMETASONE FUROATE |
COSETTE |
Labeling |
Approval |
| 06/28/2023 |
LEVOFLOXACIN
ANDA #077438 |
SUPPL-21 |
LEVOFLOXACIN |
SANDOZ |
Labeling |
Approval |
| 06/28/2023 |
MOMETASONE FUROATE
ANDA #077447 |
SUPPL-11 |
MOMETASONE FUROATE |
COSETTE |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #077587 |
SUPPL-3 |
GALANTAMINE HYDROBROMIDE |
CHARTWELL RX |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #077589 |
SUPPL-5 |
GALANTAMINE HYDROBROMIDE |
SANDOZ |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #077590 |
SUPPL-13 |
GALANTAMINE HYDROBROMIDE |
MYLAN |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #077604 |
SUPPL-3 |
GALANTAMINE HYDROBROMIDE |
YABAO PHARM |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #077604 |
SUPPL-4 |
GALANTAMINE HYDROBROMIDE |
YABAO PHARM |
Labeling |
Approval |
| 06/28/2023 |
LEVOFLOXACIN
ANDA #077652 |
SUPPL-18 |
LEVOFLOXACIN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 06/28/2023 |
CABERGOLINE
ANDA #077750 |
SUPPL-11 |
CABERGOLINE |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #077781 |
SUPPL-10 |
GALANTAMINE HYDROBROMIDE |
APOTEX INC |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #078484 |
SUPPL-10 |
GALANTAMINE HYDROBROMIDE |
IMPAX LABS |
Labeling |
Approval |
| 06/28/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #078484 |
SUPPL-11 |
GALANTAMINE HYDROBROMIDE |
IMPAX LABS |
Labeling |
Approval |
| 06/28/2023 |
SPIRONOLACTONE
ANDA #091426 |
SUPPL-26 |
SPIRONOLACTONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/28/2023 |
CLARITHROMYCIN
ANDA #202710 |
SUPPL-3 |
CLARITHROMYCIN |
STRIDES PHARMA |
Labeling |
Approval |
| 06/28/2023 |
CLARITHROMYCIN
ANDA #202710 |
SUPPL-4 |
CLARITHROMYCIN |
STRIDES PHARMA |
Labeling |
Approval |
| 06/28/2023 |
CLARITHROMYCIN
ANDA #202710 |
SUPPL-5 |
CLARITHROMYCIN |
STRIDES PHARMA |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #204290 |
SUPPL-12 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #204290 |
SUPPL-13 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #204290 |
SUPPL-17 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #204290 |
SUPPL-26 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #205695 |
SUPPL-1 |
MONTELUKAST SODIUM |
ANBISON LAB |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #205695 |
SUPPL-4 |
MONTELUKAST SODIUM |
ANBISON LAB |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #208621 |
SUPPL-1 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #208621 |
SUPPL-2 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #208621 |
SUPPL-4 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
MONTELUKAST SODIUM
ANDA #208621 |
SUPPL-9 |
MONTELUKAST SODIUM |
UNICHEM |
Labeling |
Approval |
| 06/28/2023 |
CAPLYTA
NDA #209500 |
SUPPL-11 |
LUMATEPERONE TOSYLATE |
INTRA-CELLULAR |
Labeling |
Approval |
| 06/28/2023 |
SUNOSI
NDA #211230 |
SUPPL-9 |
SOLRIAMFETOL HYDROCHLORIDE |
AXSOME MALTA |
Labeling |
Approval |
| 06/28/2023 |
CLORAZEPATE DIPOTASSIUM
ANDA #213730 |
SUPPL-5 |
CLORAZEPATE DIPOTASSIUM |
NOVITIUM PHARMA |
Labeling |
Approval |
| 06/28/2023 |
QUVIVIQ
NDA #214985 |
SUPPL-5 |
DARIDOREXANT HYDROCHLORIDE |
IDORSIA |
Manufacturing (CMC) |
Approval |
| 06/28/2023 |
AZACITIDINE
ANDA #215905 |
ORIG-1 |
AZACITIDINE |
JIANGSU HANSOH PHARM |
|
Approval |
| 06/28/2023 |
MIRTAZAPINE
ANDA #216751 |
SUPPL-1 |
MIRTAZAPINE |
PRASCO |
Labeling |
Approval |
| 06/28/2023 |
SODIUM BICARBONATE
ANDA #217594 |
ORIG-1 |
SODIUM BICARBONATE |
STERISCIENCE |
|
Approval |
| 06/29/2023 |
LANTUS
BLA #021081 |
SUPPL-78 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
| 06/29/2023 |
LANTUS
BLA #021081 |
SUPPL-79 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
| 06/29/2023 |
LANTUS SOLOSTAR
BLA #021081 |
SUPPL-78 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
| 06/29/2023 |
LANTUS SOLOSTAR
BLA #021081 |
SUPPL-79 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
| 06/29/2023 |
RISPERIDONE
ANDA #078871 |
SUPPL-9 |
RISPERIDONE |
CELLTRION |
Labeling |
Approval |
| 06/29/2023 |
ARIPIPRAZOLE
ANDA #204838 |
SUPPL-1 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/29/2023 |
ARIPIPRAZOLE
ANDA #204838 |
SUPPL-2 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/29/2023 |
ARIPIPRAZOLE
ANDA #204838 |
SUPPL-3 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/29/2023 |
ARIPIPRAZOLE
ANDA #204838 |
SUPPL-8 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/29/2023 |
ARIPIPRAZOLE
ANDA #204838 |
SUPPL-9 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/29/2023 |
ARIPIPRAZOLE
ANDA #204838 |
SUPPL-13 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 06/29/2023 |
LILETTA
NDA #206229 |
SUPPL-13 |
LEVONORGESTREL |
MEDICINES360 |
Efficacy |
Approval |
| 06/29/2023 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #207011 |
SUPPL-1 |
PRAMIPEXOLE DIHYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 06/29/2023 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #207011 |
SUPPL-3 |
PRAMIPEXOLE DIHYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 06/29/2023 |
REXTOVY
NDA #208969 |
SUPPL-1 |
NALOXONE HYDROCHLORIDE |
AMPHASTAR PHARMS INC |
Labeling |
Approval |
| 06/29/2023 |
ENILLORING
ANDA #211157 |
ORIG-1 |
ETHINYL ESTRADIOL; ETONOGESTREL |
XIROMED |
|
Approval |
| 06/29/2023 |
DEOXYCHOLIC ACID
ANDA #212296 |
SUPPL-1 |
DEOXYCHOLIC ACID |
SLAYBACK PHARMA LLC |
Labeling |
Approval |
| 06/29/2023 |
SUGAMMADEX
ANDA #213915 |
ORIG-1 |
SUGAMMADEX |
MYLAN PHARMS INC |
|
Tentative Approval |
| 06/29/2023 |
VIGABATRIN
ANDA #214749 |
ORIG-1 |
VIGABATRIN |
UPSHER SMITH LABS |
|
Approval |
| 06/29/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #217489 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
HIKMA |
|
Approval |
| 06/29/2023 |
TREMFYA
BLA #761061 |
SUPPL-15 |
GUSELKUMAB |
JANSSEN BIOTECH |
|
Approval |
| 06/30/2023 |
ALPRAZOLAM
ANDA #074112 |
SUPPL-38 |
ALPRAZOLAM |
SANDOZ |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE
ANDA #077450 |
SUPPL-9 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE
ANDA #077450 |
SUPPL-13 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE
ANDA #077450 |
SUPPL-14 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE
ANDA #077450 |
SUPPL-16 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #077457 |
SUPPL-11 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #077457 |
SUPPL-15 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #077457 |
SUPPL-16 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #077457 |
SUPPL-19 |
OCTREOTIDE ACETATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 06/30/2023 |
ALPRAZOLAM
ANDA #077777 |
SUPPL-6 |
ALPRAZOLAM |
SANDOZ INC |
Labeling |
Approval |
| 06/30/2023 |
ALPRAZOLAM
ANDA #077777 |
SUPPL-7 |
ALPRAZOLAM |
SANDOZ INC |
Labeling |
Approval |
| 06/30/2023 |
RIFAMPIN
ANDA #090034 |
SUPPL-21 |
RIFAMPIN |
LUPIN PHARMS |
Labeling |
Approval |
| 06/30/2023 |
DOXYCYCLINE HYCLATE
ANDA #208765 |
SUPPL-1 |
DOXYCYCLINE HYCLATE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 06/30/2023 |
DOXYCYCLINE HYCLATE
ANDA #208765 |
SUPPL-2 |
DOXYCYCLINE HYCLATE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 06/30/2023 |
DOXYCYCLINE HYCLATE
ANDA #208765 |
SUPPL-3 |
DOXYCYCLINE HYCLATE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 06/30/2023 |
LANSOPRAZOLE
ANDA #208784 |
SUPPL-1 |
LANSOPRAZOLE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/30/2023 |
LANSOPRAZOLE
ANDA #208784 |
SUPPL-2 |
LANSOPRAZOLE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/30/2023 |
LANSOPRAZOLE
ANDA #208784 |
SUPPL-6 |
LANSOPRAZOLE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/30/2023 |
LANSOPRAZOLE
ANDA #208784 |
SUPPL-7 |
LANSOPRAZOLE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/30/2023 |
LANSOPRAZOLE
ANDA #208784 |
SUPPL-8 |
LANSOPRAZOLE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/30/2023 |
LANSOPRAZOLE
ANDA #208784 |
SUPPL-9 |
LANSOPRAZOLE |
TEVA PHARMS USA |
Labeling |
Approval |
| 06/30/2023 |
CLOBAZAM
ANDA #210039 |
SUPPL-7 |
CLOBAZAM |
AMNEAL |
Labeling |
Approval |
| 06/30/2023 |
CYANOCOBALAMIN
ANDA #210629 |
ORIG-1 |
CYANOCOBALAMIN |
LUPIN |
|
Approval |
| 06/30/2023 |
COLESEVELAM HYDROCHLORIDE
ANDA #210889 |
SUPPL-2 |
COLESEVELAM HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 06/30/2023 |
COLESEVELAM HYDROCHLORIDE
ANDA #210889 |
SUPPL-4 |
COLESEVELAM HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 06/30/2023 |
COLESEVELAM HYDROCHLORIDE
ANDA #210889 |
SUPPL-5 |
COLESEVELAM HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 06/30/2023 |
COLESEVELAM HYDROCHLORIDE
ANDA #210889 |
SUPPL-6 |
COLESEVELAM HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 06/30/2023 |
COLESEVELAM HYDROCHLORIDE
ANDA #210889 |
SUPPL-7 |
COLESEVELAM HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 06/30/2023 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #211088 |
SUPPL-1 |
PRAMIPEXOLE DIHYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 06/30/2023 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #211088 |
SUPPL-2 |
PRAMIPEXOLE DIHYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 06/30/2023 |
TEMAZEPAM
ANDA #211542 |
SUPPL-13 |
TEMAZEPAM |
ALEMBIC |
Labeling |
Approval |
| 06/30/2023 |
PALIPERIDONE PALMITATE
ANDA #211995 |
ORIG-1 |
PALIPERIDONE PALMITATE |
TOLMAR |
|
Tentative Approval |
| 06/30/2023 |
EPHEDRINE SULFATE
ANDA #212649 |
SUPPL-3 |
EPHEDRINE SULFATE |
DR REDDYS |
Labeling |
Approval |
| 06/30/2023 |
URSODIOL
ANDA #213504 |
SUPPL-3 |
URSODIOL |
STRIDES PHARMA |
Labeling |
Approval |
| 06/30/2023 |
GAVRETO
NDA #213721 |
SUPPL-11 |
PRALSETINIB |
BLUEPRINT MEDICINES |
Labeling |
Approval |
| 06/30/2023 |
METOPROLOL SUCCINATE
ANDA #213854 |
SUPPL-18 |
METOPROLOL SUCCINATE |
YICHANG HUMANWELL |
Labeling |
Approval |
| 06/30/2023 |
VARDENAFIL HYDROCHLORIDE
ANDA #214031 |
SUPPL-4 |
VARDENAFIL HYDROCHLORIDE |
ALEMBIC |
Labeling |
Approval |
| 06/30/2023 |
TOBRAMYCIN
ANDA #214478 |
ORIG-1 |
TOBRAMYCIN |
MANKIND PHARMA |
|
Approval |
| 06/30/2023 |
ETYQA
ANDA #214729 |
ORIG-1 |
ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA LTD |
|
Approval |
| 06/30/2023 |
FULVESTRANT
ANDA #215169 |
ORIG-1 |
FULVESTRANT |
EUGIA PHARMA |
|
Approval |
| 06/30/2023 |
TOBRAMYCIN
ANDA #216725 |
SUPPL-2 |
TOBRAMYCIN |
MANKIND PHARMA |
Labeling |
Approval |
| 06/30/2023 |
CYLTEZO
BLA #761058 |
SUPPL-18 |
ADALIMUMAB-ADBM |
BOEHRINGER INGELHEIM |
|
Approval |
