| 04/01/2022 |
TADALAFIL
ANDA #210567 |
SUPPL-2 |
TADALAFIL |
LUPIN LTD |
Labeling |
Approval |
| 04/01/2022 |
ZEPZELCA
NDA #213702 |
SUPPL-4 |
LURBINECTEDIN |
JAZZ |
Labeling |
Approval |
| 04/01/2022 |
LIVMARLI
NDA #214662 |
SUPPL-1 |
MARALIXIBAT CHLORIDE |
MIRUM |
Labeling |
Approval |
| 04/01/2022 |
FLUPHENAZINE HYDROCHLORIDE
ANDA #215848 |
ORIG-1 |
FLUPHENAZINE HYDROCHLORIDE |
TWI PHARMS |
|
Approval |
| 04/04/2022 |
LEVOFLOXACIN
ANDA #077652 |
SUPPL-19 |
LEVOFLOXACIN |
ZYDUS LIFESCIENCES |
Manufacturing (CMC) |
Approval |
| 04/04/2022 |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
ANDA #091087 |
ORIG-1 |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SANDOZ |
|
Approval |
| 04/04/2022 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202519 |
SUPPL-15 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/04/2022 |
DABIGATRAN ETEXILATE MESYLATE
ANDA #208046 |
ORIG-1 |
DABIGATRAN ETEXILATE MESYLATE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 04/04/2022 |
VANCOMYCIN HYDROCHLORIDE
NDA #209481 |
SUPPL-16 |
VANCOMYCIN HYDROCHLORIDE |
MYLAN LABS LTD |
Labeling |
Approval |
| 04/05/2022 |
SOLARAZE
NDA #021005 |
SUPPL-23 |
DICLOFENAC SODIUM |
FOUGERA PHARMS |
Labeling |
Approval |
| 04/05/2022 |
METRONIDAZOLE
ANDA #070035 |
SUPPL-60 |
METRONIDAZOLE |
WATSON LABS |
Labeling |
Approval |
| 04/05/2022 |
METRONIDAZOLE
ANDA #070035 |
SUPPL-61 |
METRONIDAZOLE |
WATSON LABS |
Labeling |
Approval |
| 04/05/2022 |
METRONIDAZOLE
ANDA #070044 |
SUPPL-59 |
METRONIDAZOLE |
WATSON LABS INC |
Labeling |
Approval |
| 04/05/2022 |
METRONIDAZOLE
ANDA #070044 |
SUPPL-60 |
METRONIDAZOLE |
WATSON LABS INC |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446 |
SUPPL-13 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
SANDOZ |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446 |
SUPPL-14 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
SANDOZ |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351 |
SUPPL-12 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
HIKMA |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351 |
SUPPL-13 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
HIKMA |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202414 |
SUPPL-47 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202414 |
SUPPL-49 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #202414 |
SUPPL-47 |
IRBESARTAN: HYDROCHLOROTHIAZIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 04/05/2022 |
IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #202414 |
SUPPL-49 |
IRBESARTAN: HYDROCHLOROTHIAZIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 04/05/2022 |
ZOLEDRONIC ACID
NDA #203231 |
SUPPL-19 |
ZOLEDRONIC ACID |
INFORLIFE |
Labeling |
Approval |
| 04/05/2022 |
SEVELAMER CARBONATE
ANDA #207624 |
SUPPL-3 |
SEVELAMER CARBONATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/05/2022 |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #208473 |
ORIG-1 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
PRINSTON PHARMA INC |
|
Tentative Approval |
| 04/05/2022 |
FENOFIBRATE
ANDA #209951 |
SUPPL-5 |
FENOFIBRATE |
AMNEAL |
Labeling |
Approval |
| 04/05/2022 |
FENOFIBRATE
ANDA #210476 |
SUPPL-7 |
FENOFIBRATE |
ALEMBIC |
Labeling |
Approval |
| 04/05/2022 |
FENOFIBRATE
ANDA #211122 |
SUPPL-3 |
FENOFIBRATE |
GRAVITI PHARMS |
Labeling |
Approval |
| 04/05/2022 |
IBSRELA
NDA #211801 |
SUPPL-4 |
TENAPANOR HYDROCHLORIDE |
ARDELYX INC |
Labeling |
Approval |
| 04/05/2022 |
CHLORZOXAZONE
ANDA #213126 |
ORIG-1 |
CHLORZOXAZONE |
RISING |
|
Approval |
| 04/05/2022 |
VIJOICE
NDA #215039 |
ORIG-1 |
ALPELISIB |
NOVARTIS |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
| 04/05/2022 |
IGALMI
NDA #215390 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
BIOXCEL |
Type 3 - New Dosage Form |
Approval |
| 04/06/2022 |
MOVIPREP
NDA #021881 |
SUPPL-24 |
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE |
SALIX PHARMS |
Labeling |
Approval |
| 04/06/2022 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040133 |
SUPPL-31 |
HYDROXYCHLOROQUINE SULFATE |
WATSON LABS |
Labeling |
Approval |
| 04/06/2022 |
LORAZEPAM INTENSOL
ANDA #072755 |
SUPPL-17 |
LORAZEPAM |
HIKMA |
Labeling |
Approval |
| 04/06/2022 |
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
ANDA #202912 |
SUPPL-13 |
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE |
LUPIN LTD |
Labeling |
Approval |
| 04/06/2022 |
CERIANNA
NDA #212155 |
SUPPL-14 |
FLUOROESTRADIOL F-18 |
GE HEALTHCARE |
Labeling |
Approval |
| 04/06/2022 |
FROVATRIPTAN SUCCINATE
ANDA #213891 |
ORIG-1 |
FROVATRIPTAN SUCCINATE |
RENATA |
|
Approval |
| 04/06/2022 |
DABIGATRAN ETEXILATE MESYLATE
ANDA #215233 |
ORIG-1 |
DABIGATRAN ETEXILATE MESYLATE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 04/06/2022 |
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
ANDA #215586 |
ORIG-1 |
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
RICONPHARMA LLC |
|
Approval |
| 04/07/2022 |
NATPARA
BLA #125511 |
SUPPL-28 |
PARATHYROID HORMONE |
NPS PHARMS INC |
|
Approval |
| 04/07/2022 |
GILOTRIF
NDA #201292 |
SUPPL-17 |
AFATINIB DIMALEATE |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 04/07/2022 |
ESCITALOPRAM OXALATE
ANDA #202389 |
SUPPL-8 |
ESCITALOPRAM OXALATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/07/2022 |
ESCITALOPRAM OXALATE
ANDA #202389 |
SUPPL-10 |
ESCITALOPRAM OXALATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/07/2022 |
ESCITALOPRAM OXALATE
ANDA #202389 |
SUPPL-12 |
ESCITALOPRAM OXALATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/07/2022 |
ABSORICA LD
NDA #211913 |
SUPPL-5 |
ISOTRETINOIN |
SUN PHARM |
Labeling |
Approval |
| 04/07/2022 |
POSACONAZOLE
ANDA #212500 |
ORIG-1 |
POSACONAZOLE |
DR REDDYS |
|
Approval |
| 04/07/2022 |
GANIRELIX ACETATE
ANDA #212613 |
ORIG-1 |
GANIRELIX ACETATE |
AMPHASTAR PHARMS INC |
|
Approval |
| 04/07/2022 |
NEBIVOLOL HYDROCHLORIDE
ANDA #212682 |
ORIG-1 |
NEBIVOLOL HYDROCHLORIDE |
PRINSTON INC |
|
Approval |
| 04/07/2022 |
BUTALBITAL AND ACETAMINOPHEN
ANDA #214088 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL |
SENORES PHARMS |
|
Approval |
| 04/07/2022 |
LACOSAMIDE
ANDA #214301 |
ORIG-1 |
LACOSAMIDE |
INDOCO |
|
Approval |
| 04/08/2022 |
ZOSYN
NDA #050684 |
SUPPL-100 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 04/08/2022 |
ZOSYN IN PLASTIC CONTAINER
NDA #050750 |
SUPPL-47 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 04/08/2022 |
NITROFURANTOIN
ANDA #074336 |
SUPPL-10 |
NITROFURANTOIN, MACROCRYSTALLINE |
ATHEM |
Labeling |
Approval |
| 04/08/2022 |
NITROFURANTOIN
ANDA #074336 |
SUPPL-11 |
NITROFURANTOIN, MACROCRYSTALLINE |
ATHEM |
Labeling |
Approval |
| 04/08/2022 |
ARMONAIR DIGIHALER
NDA #208798 |
SUPPL-13 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Manufacturing (CMC) |
Approval |
| 04/08/2022 |
ARMONAIR RESPICLICK
NDA #208798 |
SUPPL-13 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Manufacturing (CMC) |
Approval |
| 04/08/2022 |
POTASSIUM CITRATE
ANDA #212779 |
SUPPL-3 |
POTASSIUM CITRATE |
ANI PHARMS |
Labeling |
Approval |
| 04/08/2022 |
LIDOCAINE AND PRILOCAINE
ANDA #213923 |
ORIG-1 |
LIDOCAINE; PRILOCAINE |
ALEMBIC |
|
Approval |
| 04/08/2022 |
SITAGLIPTIN PHOSPHATE
ANDA #215155 |
ORIG-1 |
SITAGLIPTIN PHOSPHATE |
ALKEM LABS LTD |
|
Tentative Approval |
| 04/11/2022 |
LINCOCIN
NDA #050317 |
SUPPL-187 |
LINCOMYCIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 04/11/2022 |
XIGDUO XR
NDA #205649 |
SUPPL-17 |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
ASTRAZENECA AB |
Efficacy |
Approval |
| 04/11/2022 |
REGADENOSON
ANDA #207604 |
ORIG-1 |
REGADENOSON |
APOTEX |
|
Approval |
| 04/11/2022 |
NURTEC ODT
NDA #212728 |
SUPPL-9 |
RIMEGEPANT SULFATE |
PFIZER |
Efficacy |
Approval |
| 04/11/2022 |
REGADENOSON
ANDA #212806 |
ORIG-1 |
REGADENOSON |
MEITHEAL |
|
Approval |
| 04/11/2022 |
REGADENOSON
ANDA #213210 |
ORIG-1 |
REGADENOSON |
DR REDDYS |
|
Approval |
| 04/11/2022 |
REGADENOSON
ANDA #213236 |
ORIG-1 |
REGADENOSON |
ACCORD HLTHCARE |
|
Approval |
| 04/11/2022 |
IRINOTECAN HYDROCHLORIDE
ANDA #213278 |
SUPPL-1 |
IRINOTECAN HYDROCHLORIDE |
EUGIA PHARMA |
Manufacturing (CMC) |
Approval |
| 04/11/2022 |
EPOPROSTENOL
ANDA #213913 |
ORIG-1 |
EPOPROSTENOL |
MYLAN PHARMS INC |
|
Tentative Approval |
| 04/11/2022 |
GADOTERATE MEGLUMINE
ANDA #215304 |
ORIG-1 |
GADOTERATE MEGLUMINE |
HENGRUI PHARMA |
|
Approval |
| 04/11/2022 |
SUNITINIB MALATE
ANDA #215843 |
ORIG-1 |
SUNITINIB MALATE |
DR REDDYS |
|
Approval |
| 04/12/2022 |
SUBLIMAZE PRESERVATIVE FREE
NDA #016619 |
SUPPL-52 |
FENTANYL CITRATE |
RISING |
Labeling |
Approval |
| 04/12/2022 |
FUROSEMIDE
NDA #018902 |
SUPPL-33 |
FUROSEMIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/12/2022 |
LANSOPRAZOLE
ANDA #202194 |
SUPPL-11 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Manufacturing (CMC) |
Approval |
| 04/12/2022 |
APIXABAN
ANDA #210133 |
ORIG-1 |
APIXABAN |
PRINSTON PHARMA INC |
|
Tentative Approval |
| 04/12/2022 |
BETAMETHASONE DIPROPIONATE
ANDA #215847 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE |
PADAGIS ISRAEL |
|
Approval |
| 04/13/2022 |
ORENCIA
BLA #125118 |
SUPPL-235 |
ABATACEPT |
BRISTOL MYERS SQUIBB |
|
Approval |
| 04/13/2022 |
DESVENLAFAXINE SUCCINATE
ANDA #204172 |
SUPPL-20 |
DESVENLAFAXINE SUCCINATE |
LUPIN LTD |
Labeling |
Approval |
| 04/13/2022 |
ETRAVIRINE
ANDA #215402 |
ORIG-1 |
ETRAVIRINE |
CARNEGIE |
|
Approval |
| 04/13/2022 |
ALYMSYS
BLA #761231 |
ORIG-1 |
BEVACIZUMAB-MALY |
AMNEAL PHARMS LLC |
|
Approval |
| 04/14/2022 |
THYRO-TABS
NDA #021116 |
SUPPL-23 |
LEVOTHYROXINE SODIUM |
ALVOGEN |
Efficacy |
Approval |
| 04/14/2022 |
PREZISTA
NDA #021976 |
SUPPL-65 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 04/14/2022 |
PREZISTA
NDA #202895 |
SUPPL-34 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 04/14/2022 |
PREZCOBIX
NDA #205395 |
SUPPL-22 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 04/14/2022 |
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #206006 |
SUPPL-4 |
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE |
RISING |
Labeling |
Approval |
| 04/14/2022 |
SYMTUZA
NDA #210455 |
SUPPL-20 |
COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
JANSSEN PRODS |
Labeling |
Approval |
| 04/14/2022 |
DOFETILIDE
ANDA #215323 |
ORIG-1 |
DOFETILIDE |
RK PHARMA |
|
Approval |
| 04/14/2022 |
FLUPHENAZINE HYDROCHLORIDE
ANDA #215674 |
ORIG-1 |
FLUPHENAZINE HYDROCHLORIDE |
TARO |
|
Approval |
| 04/14/2022 |
EPHEDRINE SULFATE
ANDA #216129 |
ORIG-1 |
EPHEDRINE SULFATE |
MANKIND PHARMA |
|
Approval |
| 04/15/2022 |
COPAXONE
NDA #020622 |
SUPPL-114 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/15/2022 |
TRADJENTA
NDA #201280 |
SUPPL-25 |
LINAGLIPTIN |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 04/15/2022 |
JENTADUETO
NDA #201281 |
SUPPL-31 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 04/15/2022 |
DOFETILIDE
ANDA #210018 |
ORIG-1 |
DOFETILIDE |
TEVA PHARMS USA |
|
Approval |
| 04/15/2022 |
DECITABINE
ANDA #213472 |
ORIG-1 |
DECITABINE |
JIANGSU HANSOH PHARM |
|
Approval |
| 04/15/2022 |
CYANOCOBALAMIN
ANDA #214655 |
ORIG-1 |
CYANOCOBALAMIN |
ZYDUS PHARMS |
|
Approval |
| 04/15/2022 |
CYANOCOBALAMIN
ANDA #215417 |
ORIG-1 |
CYANOCOBALAMIN |
SOLA PHARMS |
|
Approval |
| 04/15/2022 |
SUCRALFATE
ANDA #215576 |
ORIG-1 |
SUCRALFATE |
AMNEAL PHARMS |
|
Approval |
| 04/18/2022 |
LUPRON DEPOT
NDA #019732 |
SUPPL-45 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Efficacy |
Approval |
| 04/18/2022 |
LUPRON DEPOT
NDA #020517 |
SUPPL-43 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Efficacy |
Approval |
| 04/18/2022 |
ZOLMITRIPTAN
ANDA #202560 |
SUPPL-2 |
ZOLMITRIPTAN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/18/2022 |
SUSVIMO
BLA #761197 |
SUPPL-2 |
RANIBIZUMAB |
GENENTECH INC |
|
Approval |
| 04/19/2022 |
BACLOFEN
ANDA #077971 |
SUPPL-3 |
BACLOFEN |
IMPAX |
Labeling |
Approval |
| 04/19/2022 |
PYRIDOSTIGMINE BROMIDE
ANDA #212405 |
ORIG-1 |
PYRIDOSTIGMINE BROMIDE |
MILLA PHARMS |
|
Approval |
| 04/19/2022 |
DOXEPIN HYDROCHLORIDE
ANDA #213796 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
EDENBRIDGE PHARMS |
|
Approval |
| 04/19/2022 |
IVABRADINE HYDROCHLORIDE
ANDA #215238 |
ORIG-1 |
IVABRADINE HYDROCHLORIDE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 04/20/2022 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040894 |
SUPPL-21 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
GENUS |
Manufacturing (CMC) |
Approval |
| 04/20/2022 |
TEMOZOLOMIDE
ANDA #078879 |
SUPPL-18 |
TEMOZOLOMIDE |
HERITAGE |
Labeling |
Approval |
| 04/20/2022 |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
ANDA #091442 |
ORIG-1 |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
APOTEX |
|
Approval |
| 04/20/2022 |
BELEODAQ
NDA #206256 |
SUPPL-4 |
BELINOSTAT |
ACROTECH BIOPHARMA |
Labeling |
Approval |
| 04/20/2022 |
THIAMINE HYDROCHLORIDE
ANDA #208703 |
ORIG-1 |
THIAMINE HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
| 04/20/2022 |
SUCCINYLCHOLINE CHLORIDE
ANDA #211432 |
SUPPL-9 |
SUCCINYLCHOLINE CHLORIDE |
AMNEAL |
Labeling |
Approval |
| 04/20/2022 |
EPTIFIBATIDE
ANDA #213081 |
SUPPL-1 |
EPTIFIBATIDE |
SHUANGCHENG |
Manufacturing (CMC) |
Approval |
| 04/20/2022 |
SUCCINYLCHOLINE CHLORIDE
ANDA #213229 |
SUPPL-3 |
SUCCINYLCHOLINE CHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/21/2022 |
CRYSELLE
ANDA #075840 |
SUPPL-26 |
ETHINYL ESTRADIOL; NORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/21/2022 |
CRYSELLE
ANDA #075840 |
SUPPL-31 |
ETHINYL ESTRADIOL; NORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/21/2022 |
ZERBAXA
NDA #206829 |
SUPPL-11 |
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM |
CUBIST PHARMS LLC |
Efficacy |
Approval |
| 04/21/2022 |
ZERBAXA
NDA #206829 |
SUPPL-12 |
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM |
CUBIST PHARMS LLC |
Efficacy |
Approval |
| 04/21/2022 |
DSUVIA
NDA #209128 |
SUPPL-5 |
SUFENTANIL CITRATE |
VERTICAL PHARMS |
REMS |
Approval |
| 04/21/2022 |
GLYCOPYRROLATE
NDA #214919 |
ORIG-1 |
GLYCOPYRROLATE |
FRESENIUS KABI USA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/21/2022 |
EPHEDRINE SULFATE
ANDA #215825 |
ORIG-1 |
EPHEDRINE SULFATE |
XIROMED |
|
Approval |
| 04/21/2022 |
CLOBETASOL PROPIONATE
ANDA #215838 |
ORIG-1 |
CLOBETASOL PROPIONATE |
ALEMBIC |
|
Approval |
| 04/22/2022 |
SYNAREL
NDA #019886 |
SUPPL-38 |
NAFARELIN ACETATE |
PFIZER |
Labeling |
Approval |
| 04/22/2022 |
LUPRON DEPOT-PED KIT
NDA #020263 |
SUPPL-50 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
| 04/22/2022 |
METADATE CD
NDA #021259 |
SUPPL-25 |
METHYLPHENIDATE HYDROCHLORIDE |
AYTU BIOPHARMA |
Labeling |
Approval |
| 04/22/2022 |
SUPPRELIN LA
NDA #022058 |
SUPPL-17 |
HISTRELIN ACETATE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/22/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #070686 |
SUPPL-37 |
ETHINYL ESTRADIOL; NORETHINDRONE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/22/2022 |
AYUNA
ANDA #206866 |
SUPPL-4 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/22/2022 |
TRIPTODUR KIT
NDA #208956 |
SUPPL-10 |
TRIPTORELIN PAMOATE |
AZURITY |
Labeling |
Approval |
| 04/22/2022 |
ENZALUTAMIDE
ANDA #209645 |
ORIG-1 |
ENZALUTAMIDE |
APOTEX |
|
Approval |
| 04/22/2022 |
PHYTONADIONE
ANDA #212424 |
ORIG-1 |
PHYTONADIONE |
CIPLA |
|
Approval |
| 04/22/2022 |
FENSOLVI KIT
NDA #213150 |
SUPPL-2 |
LEUPROLIDE ACETATE |
TOLMAR |
Labeling |
Approval |
| 04/22/2022 |
EPHEDRINE SULFATE
NDA #213994 |
SUPPL-4 |
EPHEDRINE SULFATE |
ENDO OPERATIONS |
Manufacturing (CMC) |
Approval |
| 04/22/2022 |
EPSOLAY
NDA #214510 |
ORIG-1 |
BENZOYL PEROXIDE |
GALDERMA LABS LP |
|
Approval |
| 04/22/2022 |
PHYTONADIONE
ANDA #214596 |
ORIG-1 |
PHYTONADIONE |
CIPLA |
|
Approval |
| 04/25/2022 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901 |
SUPPL-17 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 04/25/2022 |
SEVELAMER CARBONATE
ANDA #200959 |
SUPPL-3 |
SEVELAMER CARBONATE |
ARTHUR GRP |
Labeling |
Approval |
| 04/25/2022 |
VEKLURY
NDA #214787 |
SUPPL-11 |
REMDESIVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 04/26/2022 |
EVOMELA
NDA #207155 |
SUPPL-5 |
MELPHALAN HYDROCHLORIDE |
ACROTECH BIOPHARMA |
Labeling |
Approval |
| 04/26/2022 |
QUETIAPINE FUMARATE
ANDA #208781 |
ORIG-1 |
QUETIAPINE FUMARATE |
PRINSTON INC |
|
Approval |
| 04/26/2022 |
CAPLYTA
NDA #209500 |
SUPPL-9 |
LUMATEPERONE TOSYLATE |
INTRA-CELLULAR |
Manufacturing (CMC) |
Approval |
| 04/26/2022 |
KLOR-CON
ANDA #209662 |
SUPPL-3 |
POTASSIUM CHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
| 04/26/2022 |
POTASSIUM CHLORIDE
ANDA #210200 |
SUPPL-4 |
POTASSIUM CHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 04/26/2022 |
ERLEADA
NDA #210951 |
SUPPL-7 |
APALUTAMIDE |
JANSSEN BIOTECH |
Labeling |
Approval |
| 04/26/2022 |
VIVJOA
NDA #215888 |
ORIG-1 |
OTESECONAZOLE |
MYCOVIA PHARMS |
Type 1 - New Molecular Entity |
Approval |
| 04/26/2022 |
NIFEDIPINE
ANDA #216067 |
SUPPL-1 |
NIFEDIPINE |
ALKEM LABS LTD |
Manufacturing (CMC) |
Approval |
| 04/26/2022 |
CARBON DIOXIDE, USP
NDA #217332 |
ORIG-1 |
CARBON DIOXIDE |
LINDE GAS EQUIP |
|
Approval |
| 04/27/2022 |
TAXOTERE
NDA #020449 |
SUPPL-85 |
DOCETAXEL |
SANOFI AVENTIS US |
Labeling |
Approval |
| 04/27/2022 |
EUTHYROX
NDA #021292 |
SUPPL-10 |
LEVOTHYROXINE SODIUM |
PROVELL |
Labeling |
Approval |
| 04/27/2022 |
IDAMYCIN
NDA #050661 |
SUPPL-17 |
IDARUBICIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 04/27/2022 |
IDAMYCIN PFS
NDA #050734 |
SUPPL-29 |
IDARUBICIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 04/27/2022 |
MICONAZOLE 7
ANDA #074164 |
SUPPL-33 |
MICONAZOLE NITRATE |
P AND L |
Labeling |
Approval |
| 04/27/2022 |
BROMOCRIPTINE MESYLATE
ANDA #077646 |
SUPPL-9 |
BROMOCRIPTINE MESYLATE |
PADAGIS US |
Labeling |
Approval |
| 04/27/2022 |
BROMOCRIPTINE MESYLATE
ANDA #078899 |
SUPPL-8 |
BROMOCRIPTINE MESYLATE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 04/27/2022 |
GADAVIST
NDA #201277 |
SUPPL-20 |
GADOBUTROL |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/27/2022 |
EPIDUO FORTE
NDA #207917 |
SUPPL-4 |
ADAPALENE; BENZOYL PEROXIDE |
GALDERMA LABS |
Labeling |
Approval |
| 04/27/2022 |
EPIDUO FORTE
NDA #207917 |
SUPPL-8 |
ADAPALENE; BENZOYL PEROXIDE |
GALDERMA LABS |
Labeling |
Approval |
| 04/27/2022 |
EPCLUSA
NDA #208341 |
SUPPL-19 |
SOFOSBUVIR; VELPATASVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 04/27/2022 |
HYDROXYCHLOROQUINE SULFATE
ANDA #210441 |
SUPPL-8 |
HYDROXYCHLOROQUINE SULFATE |
APPCO |
Labeling |
Approval |
| 04/27/2022 |
BALVERSA
NDA #212018 |
SUPPL-2 |
ERDAFITINIB |
JANSSEN BIOTECH |
Labeling |
Approval |
| 04/27/2022 |
BALVERSA
NDA #212018 |
SUPPL-3 |
ERDAFITINIB |
JANSSEN BIOTECH |
Labeling |
Approval |
| 04/27/2022 |
RANOLAZINE
ANDA #213517 |
ORIG-1 |
RANOLAZINE |
I3 PHARMS |
|
Approval |
| 04/27/2022 |
EPCLUSA
NDA #214187 |
SUPPL-1 |
SOFOSBUVIR; VELPATASVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 04/27/2022 |
BEXAROTENE
ANDA #215398 |
ORIG-1 |
BEXAROTENE |
AMNEAL |
|
Approval |
| 04/27/2022 |
ULTOMIRIS
BLA #761108 |
SUPPL-23 |
RAVULIZUMAB-CWVZ |
ALEXION PHARM |
|
Approval |
| 04/28/2022 |
CESAMET
NDA #018677 |
SUPPL-17 |
NABILONE |
BAUSCH |
Labeling |
Approval |
| 04/28/2022 |
CEREBYX
NDA #020450 |
SUPPL-46 |
FOSPHENYTOIN SODIUM |
PARKE DAVIS |
Labeling |
Approval |
| 04/28/2022 |
ACCUNEB
NDA #020949 |
SUPPL-27 |
ALBUTEROL SULFATE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
| 04/28/2022 |
OPANA ER
NDA #021610 |
SUPPL-30 |
OXYMORPHONE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/28/2022 |
FIRAZYR
NDA #022150 |
SUPPL-14 |
ICATIBANT ACETATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/28/2022 |
MORPHINE SULFATE
NDA #202515 |
SUPPL-33 |
MORPHINE SULFATE |
HOSPIRA INC |
Labeling |
Approval |
| 04/28/2022 |
NINLARO
NDA #208462 |
SUPPL-12 |
IXAZOMIB CITRATE |
TAKEDA PHARMS USA |
Efficacy |
Approval |
| 04/28/2022 |
NINLARO
NDA #208462 |
SUPPL-13 |
IXAZOMIB CITRATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/28/2022 |
PIRFENIDONE
ANDA #212560 |
ORIG-1 |
PIRFENIDONE |
SANDOZ |
|
Approval |
| 04/28/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #213901 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
DR REDDYS LABS SA |
|
Approval |
| 04/28/2022 |
TAPENTADOL HYDROCHLORIDE
ANDA #214378 |
ORIG-1 |
TAPENTADOL HYDROCHLORIDE |
HUMANWELL PHARMACEUTICAL US INC |
|
Tentative Approval |
| 04/28/2022 |
CAMZYOS
NDA #214998 |
ORIG-1 |
MAVACAMTEN |
BRISTOL |
Type 1 - New Molecular Entity |
Approval |
| 04/28/2022 |
CUVRIOR
NDA #215760 |
ORIG-1 |
TRIENTINE TETRAHYDROCHLORIDE |
ORPHALAN |
Type 2 - New Active Ingredient |
Approval |
| 04/28/2022 |
JEMPERLI
BLA #761174 |
SUPPL-2 |
DOSTARLIMAB-GXLY |
GLAXOSMITHKLINE |
|
Approval |
| 04/29/2022 |
LOESTRIN FE 1/20
NDA #017354 |
SUPPL-54 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
LOESTRIN FE 1.5/30
NDA #017355 |
SUPPL-56 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
NORINYL 1+35 21-DAY
NDA #017565 |
SUPPL-86 |
ETHINYL ESTRADIOL; NORETHINDRONE |
ALLERGAN |
Labeling |
Approval |
| 04/29/2022 |
NORINYL 1+35 28-DAY
NDA #017565 |
SUPPL-86 |
ETHINYL ESTRADIOL; NORETHINDRONE |
ALLERGAN |
Labeling |
Approval |
| 04/29/2022 |
LO/OVRAL
NDA #017612 |
SUPPL-44 |
ETHINYL ESTRADIOL; NORGESTREL |
CADENCE HEALTH |
Labeling |
Approval |
| 04/29/2022 |
LO/OVRAL-28
NDA #017802 |
SUPPL-35 |
ETHINYL ESTRADIOL; NORGESTREL |
WYETH PHARMS |
Labeling |
Approval |
| 04/29/2022 |
LOESTRIN 21 1.5/30
NDA #017875 |
SUPPL-40 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
LOESTRIN 21 1/20
NDA #017876 |
SUPPL-39 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
NORMINEST FE
NDA #017948 |
SUPPL-47 |
ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE |
GD SEARLE LLC |
Labeling |
Approval |
| 04/29/2022 |
LO/OVRAL FE
NDA #018206 |
SUPPL-22 |
ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE |
CADENCE HEALTH |
Labeling |
Approval |
| 04/29/2022 |
NORDETTE-21
NDA #018668 |
SUPPL-42 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
NORDETTE-28
NDA #018782 |
SUPPL-41 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
NORQUEST FE
NDA #018926 |
SUPPL-14 |
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE |
PFIZER |
Labeling |
Approval |
| 04/29/2022 |
TRI-NORINYL 21-DAY
NDA #018977 |
SUPPL-43 |
ETHINYL ESTRADIOL; NORETHINDRONE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
TRI-NORINYL 28-DAY
NDA #018977 |
SUPPL-43 |
ETHINYL ESTRADIOL; NORETHINDRONE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
TRIPHASIL-28
NDA #019190 |
SUPPL-50 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
WYETH PHARMS INC |
Labeling |
Approval |
| 04/29/2022 |
TRIPHASIL-21
NDA #019192 |
SUPPL-49 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
WYETH PHARMS |
Labeling |
Approval |
| 04/29/2022 |
ORTHO TRI-CYCLEN
NDA #019697 |
SUPPL-58 |
ETHINYL ESTRADIOL; NORGESTIMATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 04/29/2022 |
ESTROSTEP 21
NDA #020130 |
SUPPL-22 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
| 04/29/2022 |
ESTROSTEP FE
NDA #020130 |
SUPPL-22 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
| 04/29/2022 |
ALESSE
NDA #020683 |
SUPPL-16 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
CADENCE HEALTH |
Labeling |
Approval |
| 04/29/2022 |
MIRCETTE
NDA #020713 |
SUPPL-12 |
DESOGESTREL; ETHINYL ESTRADIOL |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
CYCLESSA
NDA #021090 |
SUPPL-9 |
DESOGESTREL; ETHINYL ESTRADIOL |
ASPEN GLOBAL INC |
Labeling |
Approval |
| 04/29/2022 |
YASMIN
NDA #021098 |
SUPPL-30 |
DROSPIRENONE; ETHINYL ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/29/2022 |
NUVARING
NDA #021187 |
SUPPL-40 |
ETHINYL ESTRADIOL; ETONOGESTREL |
ORGANON USA ORGANON |
Labeling |
Approval |
| 04/29/2022 |
TRACLEER
NDA #021290 |
SUPPL-43 |
BOSENTAN |
ACTELION |
REMS |
Approval |
| 04/29/2022 |
SEASONALE
NDA #021544 |
SUPPL-17 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
YAZ
NDA #021676 |
SUPPL-21 |
DROSPIRENONE; ETHINYL ESTRADIOL |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/29/2022 |
SEASONIQUE
NDA #021840 |
SUPPL-15 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
LOESTRIN 24 FE
NDA #021871 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
TOTECT
NDA #022025 |
SUPPL-20 |
DEXRAZOXANE HYDROCHLORIDE |
CLINIGEN |
Labeling |
Approval |
| 04/29/2022 |
NATAZIA
NDA #022252 |
SUPPL-7 |
DIENOGEST; ESTRADIOL VALERATE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/29/2022 |
LOSEASONIQUE
NDA #022262 |
SUPPL-6 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
LO LOESTRIN FE
NDA #022501 |
SUPPL-15 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
| 04/29/2022 |
BEYAZ
NDA #022532 |
SUPPL-11 |
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
NDA #022573 |
SUPPL-14 |
ETHINYL ESTRADIOL; NORETHINDRONE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
SAFYRAL
NDA #022574 |
SUPPL-11 |
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #070684 |
SUPPL-31 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #070685 |
SUPPL-35 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON PHARMS TEVA |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #070686 |
SUPPL-38 |
ETHINYL ESTRADIOL; NORETHINDRONE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #070687 |
SUPPL-44 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS TEVA |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND MESTRANOL
ANDA #070758 |
SUPPL-17 |
MESTRANOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND MESTRANOL
ANDA #070759 |
SUPPL-18 |
MESTRANOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
ANDA #071041 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS TEVA |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
ANDA #071042 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
ANDA #071043 |
SUPPL-28 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
ANDA #071044 |
SUPPL-36 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS TEVA |
Labeling |
Approval |
| 04/29/2022 |
NORETHIN 1/35E-21
ANDA #071480 |
SUPPL-13 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON PHARMS TEVA |
Labeling |
Approval |
| 04/29/2022 |
NORETHIN 1/35E-28
ANDA #071481 |
SUPPL-16 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHIN 1/50M-21
ANDA #071539 |
SUPPL-10 |
MESTRANOL; NORETHINDRONE |
HERITAGE PHARMA |
Labeling |
Approval |
| 04/29/2022 |
NORETHIN 1/50M-28
ANDA #071540 |
SUPPL-14 |
MESTRANOL; NORETHINDRONE |
HERITAGE PHARMA |
Labeling |
Approval |
| 04/29/2022 |
NORTREL 1/35-21
ANDA #072693 |
SUPPL-32 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
GENCEPT 10/11-21
ANDA #072694 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
NORTREL 0.5/35-28
ANDA #072695 |
SUPPL-30 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
NORTREL 1/35-28
ANDA #072696 |
SUPPL-33 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
GENCEPT 10/11-28
ANDA #072697 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
ZOVIA 1/35E-21
ANDA #072720 |
SUPPL-27 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
WATSON PHARMS TEVA |
Labeling |
Approval |
| 04/29/2022 |
ZOVIA 1/35E-28
ANDA #072721 |
SUPPL-37 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
ZOVIA 1/50E-21
ANDA #072722 |
SUPPL-27 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
ZOVIA 1/50E-28
ANDA #072723 |
SUPPL-44 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
LEVORA 0.15/30-21
ANDA #073592 |
SUPPL-22 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
LEVORA 0.15/30-28
ANDA #073594 |
SUPPL-31 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
LORAZEPAM
ANDA #074243 |
SUPPL-41 |
LORAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 04/29/2022 |
LORAZEPAM
ANDA #074282 |
SUPPL-23 |
LORAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 04/29/2022 |
TRIVORA-21
ANDA #074538 |
SUPPL-28 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
TRIVORA-28
ANDA #074538 |
SUPPL-28 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #075256 |
SUPPL-41 |
DESOGESTREL; ETHINYL ESTRADIOL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/29/2022 |
LOW-OGESTREL-21
ANDA #075288 |
SUPPL-24 |
ETHINYL ESTRADIOL; NORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
LOW-OGESTREL-28
ANDA #075288 |
SUPPL-24 |
ETHINYL ESTRADIOL; NORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
OGESTREL 0.5/50-21
ANDA #075406 |
SUPPL-26 |
ETHINYL ESTRADIOL; NORGESTREL |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
OGESTREL 0.5/50-28
ANDA #075406 |
SUPPL-26 |
ETHINYL ESTRADIOL; NORGESTREL |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORTREL 7/7/7
ANDA #075478 |
SUPPL-22 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
AVIANE-21
ANDA #075796 |
SUPPL-28 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/29/2022 |
AVIANE-28
ANDA #075796 |
SUPPL-28 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/29/2022 |
LESSINA-21
ANDA #075803 |
SUPPL-34 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
BARR |
Labeling |
Approval |
| 04/29/2022 |
LESSINA-28
ANDA #075803 |
SUPPL-34 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
BARR |
Labeling |
Approval |
| 04/29/2022 |
SPRINTEC
ANDA #075804 |
SUPPL-36 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
TRI-SPRINTEC
ANDA #075808 |
SUPPL-40 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
ENPRESSE-21
ANDA #075809 |
SUPPL-31 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/29/2022 |
ENPRESSE-28
ANDA #075809 |
SUPPL-31 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/29/2022 |
CRYSELLE
ANDA #075840 |
SUPPL-32 |
ETHINYL ESTRADIOL; NORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 04/29/2022 |
KARIVA
ANDA #075863 |
SUPPL-34 |
DESOGESTREL; ETHINYL ESTRADIOL |
BARR |
Labeling |
Approval |
| 04/29/2022 |
PORTIA-21
ANDA #075866 |
SUPPL-32 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
BARR |
Labeling |
Approval |
| 04/29/2022 |
PORTIA-28
ANDA #075866 |
SUPPL-32 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
BARR |
Labeling |
Approval |
| 04/29/2022 |
BALZIVA-28
ANDA #076238 |
SUPPL-25 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
PREVIFEM
ANDA #076334 |
SUPPL-24 |
ETHINYL ESTRADIOL; NORGESTIMATE |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 04/29/2022 |
TRI-PREVIFEM
ANDA #076335 |
SUPPL-21 |
ETHINYL ESTRADIOL; NORGESTIMATE |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 04/29/2022 |
CYCLAFEM 1/35
ANDA #076337 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 04/29/2022 |
CYCLAFEM 7/7/7
ANDA #076338 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #076393 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #076625 |
SUPPL-17 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #076626 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #076627 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #076629 |
SUPPL-11 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
EMOQUETTE
ANDA #076675 |
SUPPL-13 |
DESOGESTREL; ETHINYL ESTRADIOL |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 04/29/2022 |
KIMIDESS
ANDA #076681 |
SUPPL-5 |
DESOGESTREL; ETHINYL ESTRADIOL |
VINTAGE PHARMS |
Labeling |
Approval |
| 04/29/2022 |
ARANELLE
ANDA #076783 |
SUPPL-16 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
TRI LO SPRINTEC
ANDA #076784 |
SUPPL-13 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR LABS INC |
Labeling |
Approval |
| 04/29/2022 |
KELNOR
ANDA #076785 |
SUPPL-20 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #076915 |
SUPPL-21 |
DESOGESTREL; ETHINYL ESTRADIOL |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #076916 |
SUPPL-13 |
DESOGESTREL; ETHINYL ESTRADIOL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
ORSYTHIA
ANDA #077099 |
SUPPL-8 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 04/29/2022 |
MYZILRA
ANDA #077502 |
SUPPL-8 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #077681 |
SUPPL-15 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #078267 |
SUPPL-15 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #078323 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
GILDAGIA
ANDA #078376 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
VINTAGE PHARMS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #078379 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #078892 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #078965 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 04/29/2022 |
ALTAVERA
ANDA #079102 |
SUPPL-12 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #079218 |
SUPPL-12 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #090479 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE; ETHINYL ESTRADIOL
ANDA #090479 |
SUPPL-2 |
NORGESTIMATE; ETHINYL ESTRADIOL |
WATSON LABS |
Labeling |
Approval |
| 04/29/2022 |
MONO-LINYAH
ANDA #090523 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
TRI-LINYAH
ANDA #090524 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
BRIELLYN
ANDA #090538 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORETHINDRONE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
LEVONEST
ANDA #090719 |
SUPPL-8 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
FALMINA
ANDA #090721 |
SUPPL-7 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
TRI-ESTARYLLA
ANDA #090793 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
ESTARYLLA
ANDA #090794 |
SUPPL-11 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
FERROUS FUMARATE
ANDA #090938 |
SUPPL-12 |
FERROUS FUMARATE |
BARR LABS INC |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #090938 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
BARR LABS INC |
Labeling |
Approval |
| 04/29/2022 |
DASETTA 7/7/7
ANDA #090946 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
PHILITH
ANDA #090947 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
DASETTA 1/35
ANDA #090948 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
WERA
ANDA #091204 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
TRI-LO-ESTARYLLA
ANDA #091232 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #091234 |
SUPPL-12 |
DESOGESTREL; ETHINYL ESTRADIOL |
NOVAST LABS |
Labeling |
Approval |
| 04/29/2022 |
PIMTREA
ANDA #091247 |
SUPPL-9 |
DESOGESTREL; ETHINYL ESTRADIOL |
NOVAST LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #091332 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
VIORELE
ANDA #091346 |
SUPPL-11 |
DESOGESTREL; ETHINYL ESTRADIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
BLISOVI 24 FE
ANDA #091398 |
SUPPL-20 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
KURVELO
ANDA #091408 |
SUPPL-14 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #091425 |
SUPPL-10 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
MARLISSA
ANDA #091452 |
SUPPL-9 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #091663 |
SUPPL-12 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
DOLISHALE
ANDA #091692 |
SUPPL-3 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
NOVAST LABS |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200245 |
SUPPL-8 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200248 |
SUPPL-8 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200383 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NAARI PTE LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200384 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NAARI PTE LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200494 |
SUPPL-14 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE; ETHINYL ESTRADIOL
ANDA #200494 |
SUPPL-14 |
NORGESTIMATE; ETHINYL ESTRADIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200538 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200541 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN PHARMS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #200897 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
XULANE
ANDA #200910 |
SUPPL-14 |
ETHINYL ESTRADIOL; NORELGESTROMIN |
MYLAN TECHNOLOGIES |
Labeling |
Approval |
| 04/29/2022 |
VIENVA
ANDA #201088 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #201095 |
SUPPL-3 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #201108 |
SUPPL-4 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/29/2022 |
PIRMELLA 7/7/7
ANDA #201510 |
SUPPL-13 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
PIRMELLA 1/35
ANDA #201512 |
SUPPL-13 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
VYFEMLA
ANDA #201886 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
ENSKYCE
ANDA #201887 |
SUPPL-19 |
DESOGESTREL; ETHINYL ESTRADIOL |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201896 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORGESTIMATE |
MYLAN |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201897 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORGESTIMATE |
MYLAN |
Labeling |
Approval |
| 04/29/2022 |
DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #202085 |
SUPPL-6 |
DESOGESTREL; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202086 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORETHINDRONE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #202132 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORGESTIMATE |
MYLAN LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
BEKYREE
ANDA #202226 |
SUPPL-12 |
DESOGESTREL; ETHINYL ESTRADIOL |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202247 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #202296 |
SUPPL-6 |
DESOGESTREL; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
TRANEXAMIC ACID
ANDA #202436 |
SUPPL-6 |
TRANEXAMIC ACID |
ACIC PHARMS |
Labeling |
Approval |
| 04/29/2022 |
ELIFEMME
ANDA #202507 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
VOLNEA
ANDA #202689 |
SUPPL-5 |
DESOGESTREL; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
ISIBLOOM
ANDA #202789 |
SUPPL-7 |
DESOGESTREL; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202791 |
SUPPL-6 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
CERINTA
ANDA #202817 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
SUN PHARM |
Labeling |
Approval |
| 04/29/2022 |
CHABELINA FE
ANDA #202962 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202970 |
SUPPL-3 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
MYLAN LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
LARIN 24 FE
ANDA #202994 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #203006 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
CYCLAFEM 0.5/35
ANDA #203413 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/29/2022 |
MINASTRIN 24 FE
NDA #203667 |
SUPPL-14 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #203865 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #203870 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #203873 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/29/2022 |
TWIRLA
NDA #204017 |
SUPPL-4 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AGILE |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #204057 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS |
Labeling |
Approval |
| 04/29/2022 |
QUARTETTE
NDA #204061 |
SUPPL-8 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 04/29/2022 |
TAYTULLA
NDA #204426 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
| 04/29/2022 |
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
ANDA #204703 |
SUPPL-4 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
ANDA #204704 |
SUPPL-4 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
HAILEY 24 FE
ANDA #204847 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #205069 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/29/2022 |
TRI-MILI
ANDA #205441 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/29/2022 |
MILI
ANDA #205449 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #205588 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #205630 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN LTD |
Labeling |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #205699 |
SUPPL-3 |
BOSENTAN |
ENDO OPERATIONS |
REMS |
Approval |
| 04/29/2022 |
TRI-LO-MILI
ANDA #205762 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #206002 |
SUPPL-3 |
BOSENTAN |
ALVOGEN PINE BROOK |
REMS |
Approval |
| 04/29/2022 |
SIMLIYA
ANDA #206853 |
SUPPL-5 |
DESOGESTREL; ETHINYL ESTRADIOL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #206864 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NAARI PTE LTD |
Labeling |
Approval |
| 04/29/2022 |
AYUNA
ANDA #206866 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
AFIRMELLE
ANDA #206886 |
SUPPL-2 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #206987 |
SUPPL-4 |
BOSENTAN |
NATCO PHARMA LTD |
REMS |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #207033 |
SUPPL-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
NAARI PTE LTD |
Labeling |
Approval |
| 04/29/2022 |
NYLIA 7/7/7
ANDA #207054 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
CYONANZ
ANDA #207055 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
NYLIA 1/35
ANDA #207056 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #207065 |
SUPPL-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
NAARI PTE LTD |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #207066 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NAARI PTE LTD |
Labeling |
Approval |
| 04/29/2022 |
DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #207067 |
SUPPL-2 |
DESOGESTREL; ETHINYL ESTRADIOL |
NAARI PTE LTD |
Labeling |
Approval |
| 04/29/2022 |
KALLIGA
ANDA #207081 |
SUPPL-4 |
DESOGESTREL; ETHINYL ESTRADIOL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #207110 |
SUPPL-5 |
BOSENTAN |
WATSON LABS INC |
REMS |
Approval |
| 04/29/2022 |
AUROVELA 24 FE
ANDA #207504 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
NEXESTA FE
ANDA #207535 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #207760 |
SUPPL-6 |
BOSENTAN |
ZYDUS PHARMS |
REMS |
Approval |
| 04/29/2022 |
BALCOLTRA
NDA #208612 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AVION PHARMS |
Labeling |
Approval |
| 04/29/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #208639 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APOTEX |
Labeling |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #208695 |
SUPPL-3 |
BOSENTAN |
HIKMA |
REMS |
Approval |
| 04/29/2022 |
TRACLEER
NDA #209279 |
SUPPL-9 |
BOSENTAN |
ACTELION |
REMS |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #209324 |
SUPPL-6 |
BOSENTAN |
SUN PHARM |
REMS |
Approval |
| 04/29/2022 |
TYBLUME
NDA #209405 |
SUPPL-2 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
EXELTIS USA INC |
Labeling |
Approval |
| 04/29/2022 |
ANNOVERA
NDA #209627 |
SUPPL-3 |
ETHINYL ESTRADIOL; SEGESTERONE ACETATE |
MAYNE PHARMA |
Labeling |
Approval |
| 04/29/2022 |
BOSENTAN
ANDA #209742 |
SUPPL-5 |
BOSENTAN |
AMNEAL PHARMS CO |
REMS |
Approval |
| 04/29/2022 |
RINVOQ
NDA #211675 |
SUPPL-3 |
UPADACITINIB |
ABBVIE |
Efficacy |
Approval |
| 04/29/2022 |
QELBREE
NDA #211964 |
SUPPL-3 |
VILOXAZINE HYDROCHLORIDE |
SUPERNUS PHARMS |
Efficacy |
Approval |
| 04/29/2022 |
SILDENAFIL CITRATE
ANDA #212440 |
SUPPL-3 |
SILDENAFIL CITRATE |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/29/2022 |
CROMOLYN SODIUM
ANDA #213658 |
ORIG-1 |
CROMOLYN SODIUM |
MICRO LABS |
|
Approval |
| 04/29/2022 |
ETHINYL ESTRADIOL AND NORELGESTROMIN
ANDA #213950 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORELGESTROMIN |
AMNEAL |
Labeling |
Approval |
| 04/29/2022 |
ONSURA
ANDA #213977 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORELGESTROMIN |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/29/2022 |
ISOSORBIDE MONONITRATE
ANDA #214115 |
ORIG-1 |
ISOSORBIDE MONONITRATE |
SHANDONG |
|
Approval |
| 04/29/2022 |
NEXTSTELLIS
NDA #214154 |
SUPPL-2 |
DROSPIRENONE; ESTETROL |
MAYNE PHARMA |
Labeling |
Approval |
| 04/29/2022 |
ERMEZA
NDA #215809 |
ORIG-1 |
LEVOTHYROXINE SODIUM |
MYLAN |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/29/2022 |
ADUHELM
BLA #761178 |
SUPPL-5 |
ADUCANUMAB-AVWA |
BIOGEN INC |
|
Approval |
