| 02/01/2021 |
DOCEFREZ
NDA #022534 |
SUPPL-12 |
DOCETAXEL |
SUN PHARM |
Labeling |
Approval |
| 02/01/2021 |
DOCETAXEL
NDA #022534 |
SUPPL-12 |
DOCETAXEL |
SUN PHARM |
Labeling |
Approval |
| 02/01/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071297 |
SUPPL-33 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 02/01/2021 |
LEUPROLIDE ACETATE
ANDA #074728 |
SUPPL-20 |
LEUPROLIDE ACETATE |
SANDOZ |
Labeling |
Approval |
| 02/01/2021 |
LEUPROLIDE ACETATE
ANDA #074728 |
SUPPL-22 |
LEUPROLIDE ACETATE |
SANDOZ |
Labeling |
Approval |
| 02/01/2021 |
PRAVASTATIN SODIUM
ANDA #077917 |
SUPPL-19 |
PRAVASTATIN SODIUM |
CHARTWELL RX |
Labeling |
Approval |
| 02/01/2021 |
PRAVASTATIN SODIUM
ANDA #077987 |
SUPPL-16 |
PRAVASTATIN SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/01/2021 |
SIMPONI ARIA
BLA #125433 |
SUPPL-32 |
GOLIMUMAB |
JANSSEN BIOTECH |
|
Approval |
| 02/01/2021 |
ARIPIPRAZOLE
ANDA #202102 |
SUPPL-18 |
ARIPIPRAZOLE |
ALEMBIC |
Labeling |
Approval |
| 02/01/2021 |
ARIPIPRAZOLE
ANDA #202547 |
SUPPL-3 |
ARIPIPRAZOLE |
ORBION PHARMS |
Labeling |
Approval |
| 02/01/2021 |
LAMOTRIGINE
ANDA #202887 |
SUPPL-17 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 02/01/2021 |
TIGECYCLINE
ANDA #204439 |
SUPPL-3 |
TIGECYCLINE |
APOTEX |
Labeling |
Approval |
| 02/01/2021 |
POSIMIR
NDA #204803 |
ORIG-1 |
BUPIVACAINE |
INNOCOLL |
Type 3 - New Dosage Form |
Approval |
| 02/01/2021 |
CEFAZOLIN IN DEXTROSE
NDA #207131 |
SUPPL-6 |
CEFAZOLIN SODIUM |
BAXTER HLTHCARE CORP |
Efficacy |
Approval |
| 02/01/2021 |
ARIPIPRAZOLE
ANDA #207240 |
SUPPL-6 |
ARIPIPRAZOLE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 02/01/2021 |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #208427 |
ORIG-1 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
DR REDDYS LABS LTD |
|
Tentative Approval |
| 02/01/2021 |
GOCOVRI
NDA #208944 |
SUPPL-4 |
AMANTADINE HYDROCHLORIDE |
SUPERNUS PHARMS |
Efficacy |
Approval |
| 02/01/2021 |
POTASSIUM CHLORIDE
ANDA #209688 |
SUPPL-1 |
POTASSIUM CHLORIDE |
TWI PHARMS |
Labeling |
Approval |
| 02/01/2021 |
TOPIRAMATE
ANDA #210278 |
ORIG-1 |
TOPIRAMATE |
GLENMARK PHARMS LTD |
|
Approval |
| 02/01/2021 |
ORILISSA
NDA #210450 |
SUPPL-4 |
ELAGOLIX SODIUM |
ABBVIE |
Efficacy |
Approval |
| 02/01/2021 |
ORILISSA
NDA #210450 |
SUPPL-5 |
ELAGOLIX SODIUM |
ABBVIE |
Efficacy |
Approval |
| 02/01/2021 |
ORILISSA
NDA #210450 |
SUPPL-6 |
ELAGOLIX SODIUM |
ABBVIE |
Efficacy |
Approval |
| 02/01/2021 |
LANSOPRAZOLE
ANDA #210465 |
ORIG-1 |
LANSOPRAZOLE |
DR REDDYS |
|
Approval |
| 02/01/2021 |
POSACONAZOLE
ANDA #213454 |
ORIG-1 |
POSACONAZOLE |
AET PHARMA |
|
Approval |
| 02/02/2021 |
NIZORAL ANTI-DANDRUFF
NDA #020310 |
SUPPL-26 |
KETOCONAZOLE |
KRAMER |
Labeling |
Approval |
| 02/02/2021 |
DIPYRIDAMOLE
ANDA #040733 |
SUPPL-6 |
DIPYRIDAMOLE |
RISING |
Labeling |
Approval |
| 02/02/2021 |
MORPHINE SULFATE
ANDA #079040 |
SUPPL-20 |
MORPHINE SULFATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 02/02/2021 |
CARBIDOPA AND LEVODOPA
ANDA #090324 |
SUPPL-8 |
CARBIDOPA; LEVODOPA |
MYLAN |
Labeling |
Approval |
| 02/02/2021 |
NEULASTA
BLA #125031 |
SUPPL-203 |
PEGFILGRASTIM |
AMGEN |
|
Approval |
| 02/02/2021 |
QUETIAPINE FUMARATE
ANDA #202228 |
ORIG-1 |
QUETIAPINE FUMARATE |
RISING PHARMA |
|
Approval |
| 02/02/2021 |
LURASIDONE HYDROCHLORIDE
ANDA #208016 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
WATSON LABS TEVA |
|
Approval |
| 02/02/2021 |
FENOFIBRATE
ANDA #211080 |
SUPPL-1 |
FENOFIBRATE |
PRINSTON INC |
Labeling |
Approval |
| 02/02/2021 |
BUPRENORPHINE
ANDA #211586 |
SUPPL-3 |
BUPRENORPHINE |
AMNEAL |
Labeling |
Approval |
| 02/02/2021 |
ZIPRASIDONE MESYLATE
ANDA #211908 |
SUPPL-1 |
ZIPRASIDONE MESYLATE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 02/02/2021 |
ZIPRASIDONE MESYLATE
ANDA #211908 |
SUPPL-2 |
ZIPRASIDONE MESYLATE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 02/02/2021 |
TOLTERODINE TARTRATE
ANDA #213858 |
ORIG-1 |
TOLTERODINE TARTRATE |
AMTA |
|
Approval |
| 02/03/2021 |
PROMACTA
NDA #022291 |
SUPPL-31 |
ELTROMBOPAG OLAMINE |
NOVARTIS |
Labeling |
Approval |
| 02/03/2021 |
PROMACTA KIT
NDA #207027 |
SUPPL-14 |
ELTROMBOPAG OLAMINE |
NOVARTIS |
Labeling |
Approval |
| 02/03/2021 |
TAVABOROLE
ANDA #211963 |
ORIG-1 |
TAVABOROLE |
CHARTWELL RX |
|
Approval |
| 02/03/2021 |
TEPMETKO
NDA #214096 |
ORIG-1 |
TEPOTINIB HYDROCHLORIDE |
EMD SERONO INC |
Type 1 - New Molecular Entity |
Approval |
| 02/03/2021 |
AIMOVIG
BLA #761077 |
SUPPL-9 |
ERENUMAB-AOOE |
AMGEN INC |
|
Approval |
| 02/04/2021 |
CYKLOKAPRON
NDA #019281 |
SUPPL-47 |
TRANEXAMIC ACID |
PFIZER |
Labeling |
Approval |
| 02/04/2021 |
ADRENACLICK
NDA #020800 |
SUPPL-40 |
EPINEPHRINE |
IMPAX |
Labeling |
Approval |
| 02/04/2021 |
TWINJECT 0.15
NDA #020800 |
SUPPL-40 |
EPINEPHRINE |
IMPAX |
Labeling |
Approval |
| 02/04/2021 |
TWINJECT 0.3
NDA #020800 |
SUPPL-40 |
EPINEPHRINE |
IMPAX |
Labeling |
Approval |
| 02/04/2021 |
AMBISOME
NDA #050740 |
SUPPL-33 |
AMPHOTERICIN B |
ASTELLAS |
Labeling |
Approval |
| 02/04/2021 |
CARBIDOPA AND LEVODOPA
ANDA #074260 |
SUPPL-55 |
CARBIDOPA; LEVODOPA |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 02/04/2021 |
SOTALOL HYDROCHLORIDE
ANDA #075429 |
SUPPL-18 |
SOTALOL HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
| 02/04/2021 |
SORINE
ANDA #075500 |
SUPPL-17 |
SOTALOL HYDROCHLORIDE |
AIPING PHARM INC |
Labeling |
Approval |
| 02/04/2021 |
CARBIDOPA AND LEVODOPA
ANDA #077120 |
SUPPL-7 |
CARBIDOPA; LEVODOPA |
APOTEX INC |
Labeling |
Approval |
| 02/04/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077742 |
SUPPL-11 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
ENDO OPERATIONS |
Labeling |
Approval |
| 02/04/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077742 |
SUPPL-12 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
ENDO OPERATIONS |
Labeling |
Approval |
| 02/04/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077742 |
SUPPL-18 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
ENDO OPERATIONS |
Labeling |
Approval |
| 02/04/2021 |
NEUPOGEN
BLA #103353 |
SUPPL-5197 |
FILGRASTIM |
AMGEN |
|
Approval |
| 02/04/2021 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 02/04/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #202321 |
SUPPL-2 |
OXYMORPHONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 02/04/2021 |
NEOSTIGMINE METHYLSULFATE
NDA #203629 |
SUPPL-3 |
NEOSTIGMINE METHYLSULFATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 02/04/2021 |
DIAZEPAM
ANDA #204433 |
SUPPL-3 |
DIAZEPAM |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 02/04/2021 |
OSELTAMIVIR PHOSPHATE
ANDA #208348 |
SUPPL-7 |
OSELTAMIVIR PHOSPHATE |
LUPIN |
Labeling |
Approval |
| 02/05/2021 |
LIBRAX
NDA #012750 |
SUPPL-67 |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
BAUSCH |
Labeling |
Approval |
| 02/05/2021 |
VALIUM
NDA #013263 |
SUPPL-96 |
DIAZEPAM |
WAYLIS THERAP |
Labeling |
Approval |
| 02/05/2021 |
LIMBITROL
NDA #016949 |
SUPPL-41 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/05/2021 |
LIMBITROL DS
NDA #016949 |
SUPPL-41 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/05/2021 |
TRANXENE
NDA #017105 |
SUPPL-84 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Labeling |
Approval |
| 02/05/2021 |
TRANXENE SD
NDA #017105 |
SUPPL-84 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Labeling |
Approval |
| 02/05/2021 |
KLONOPIN
NDA #017533 |
SUPPL-61 |
CLONAZEPAM |
CHEPLAPHARM |
Labeling |
Approval |
| 02/05/2021 |
ATIVAN
NDA #017794 |
SUPPL-48 |
LORAZEPAM |
BAUSCH |
Labeling |
Approval |
| 02/05/2021 |
HALCION
NDA #017892 |
SUPPL-55 |
TRIAZOLAM |
PFIZER |
Labeling |
Approval |
| 02/05/2021 |
ATIVAN
NDA #018140 |
SUPPL-46 |
LORAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
RESTORIL
NDA #018163 |
SUPPL-67 |
TEMAZEPAM |
SPECGX LLC |
Labeling |
Approval |
| 02/05/2021 |
XANAX
NDA #018276 |
SUPPL-58 |
ALPRAZOLAM |
UPJOHN |
Labeling |
Approval |
| 02/05/2021 |
DORAL
NDA #018708 |
SUPPL-27 |
QUAZEPAM |
GALT PHARMS |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
NDA #020124 |
SUPPL-33 |
DIAZEPAM |
US ARMY |
Labeling |
Approval |
| 02/05/2021 |
DIASTAT
NDA #020648 |
SUPPL-21 |
DIAZEPAM |
BAUSCH |
Labeling |
Approval |
| 02/05/2021 |
DIASTAT ACUDIAL
NDA #020648 |
SUPPL-21 |
DIAZEPAM |
BAUSCH |
Labeling |
Approval |
| 02/05/2021 |
XANAX XR
NDA #021434 |
SUPPL-21 |
ALPRAZOLAM |
UPJOHN |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #070311 |
SUPPL-18 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #070311 |
SUPPL-19 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #070312 |
SUPPL-16 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #070313 |
SUPPL-22 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #070683 |
SUPPL-14 |
OXAZEPAM |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070765 |
SUPPL-25 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
ANDA REPOSITORY |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070766 |
SUPPL-21 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
ANDA REPOSITORY |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #070928 |
SUPPL-18 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #070943 |
SUPPL-34 |
OXAZEPAM |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #070944 |
SUPPL-34 |
OXAZEPAM |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #070945 |
SUPPL-36 |
OXAZEPAM |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #071026 |
SUPPL-20 |
OXAZEPAM |
UNITED RES LABS |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071297 |
SUPPL-36 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #071308 |
SUPPL-7 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #071309 |
SUPPL-7 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #071310 |
SUPPL-8 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM INTENSOL
ANDA #071415 |
SUPPL-17 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #071583 |
SUPPL-25 |
DIAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #071756 |
SUPPL-24 |
OXAZEPAM |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #071813 |
SUPPL-24 |
OXAZEPAM |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #071814 |
SUPPL-22 |
OXAZEPAM |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072052 |
SUPPL-11 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
HERITAGE PHARMA |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072053 |
SUPPL-11 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
HERITAGE PHARMA |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #072079 |
SUPPL-44 |
DIAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #072253 |
SUPPL-39 |
OXAZEPAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072277 |
SUPPL-14 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072278 |
SUPPL-14 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #072952 |
SUPPL-6 |
OXAZEPAM |
WATSON LABS TEVA |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #072953 |
SUPPL-6 |
OXAZEPAM |
WATSON LABS |
Labeling |
Approval |
| 02/05/2021 |
OXAZEPAM
ANDA #072954 |
SUPPL-6 |
OXAZEPAM |
WATSON LABS |
Labeling |
Approval |
| 02/05/2021 |
ESTAZOLAM
ANDA #074818 |
SUPPL-27 |
ESTAZOLAM |
WATSON LABS |
Labeling |
Approval |
| 02/05/2021 |
ESTAZOLAM
ANDA #074826 |
SUPPL-19 |
ESTAZOLAM |
NOVITIUM PHARMA |
Labeling |
Approval |
| 02/05/2021 |
ESTAZOLAM
ANDA #074921 |
SUPPL-19 |
ESTAZOLAM |
DR REDDYS LABS SA |
Labeling |
Approval |
| 02/05/2021 |
CLONAZEPAM
ANDA #077171 |
SUPPL-17 |
CLONAZEPAM |
ENDO OPERATIONS |
Labeling |
Approval |
| 02/05/2021 |
CLONAZEPAM
ANDA #077194 |
SUPPL-10 |
CLONAZEPAM |
BARR |
Labeling |
Approval |
| 02/05/2021 |
ALPRAZOLAM
ANDA #078088 |
SUPPL-13 |
ALPRAZOLAM |
ENDO OPERATIONS |
Labeling |
Approval |
| 02/05/2021 |
ALPRAZOLAM
ANDA #078561 |
SUPPL-22 |
ALPRAZOLAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 02/05/2021 |
CLONAZEPAM
ANDA #078654 |
SUPPL-8 |
CLONAZEPAM |
SUN PHARM INDS INC |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #083116 |
SUPPL-113 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #084768 |
SUPPL-93 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #084769 |
SUPPL-96 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 02/05/2021 |
LIBRIUM
ANDA #085461 |
SUPPL-56 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
VALEANT PHARM INTL |
Labeling |
Approval |
| 02/05/2021 |
LIBRIUM
ANDA #085472 |
SUPPL-48 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
VALEANT PHARM INTL |
Labeling |
Approval |
| 02/05/2021 |
LIBRIUM
ANDA #085475 |
SUPPL-51 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
BAUSCH |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #086294 |
SUPPL-40 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #086382 |
SUPPL-34 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
| 02/05/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #086383 |
SUPPL-37 |
CHLORDIAZEPOXIDE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
| 02/05/2021 |
ONFI
NDA #202067 |
SUPPL-6 |
CLOBAZAM |
LUNDBECK PHARMS LLC |
Labeling |
Approval |
| 02/05/2021 |
ONFI
NDA #203993 |
SUPPL-8 |
CLOBAZAM |
LUNDBECK PHARMS LLC |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #204433 |
SUPPL-6 |
DIAZEPAM |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 02/05/2021 |
DIAZEPAM
ANDA #206477 |
SUPPL-2 |
DIAZEPAM |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 02/05/2021 |
ROSUVASTATIN CALCIUM
ANDA #207653 |
ORIG-1 |
ROSUVASTATIN CALCIUM |
INVENTIA |
|
Approval |
| 02/05/2021 |
SEIZALAM
NDA #209566 |
SUPPL-1 |
MIDAZOLAM HYDROCHLORIDE |
MMT |
Labeling |
Approval |
| 02/05/2021 |
BIKTARVY
NDA #210251 |
SUPPL-7 |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 02/05/2021 |
SYMPAZAN
NDA #210833 |
SUPPL-3 |
CLOBAZAM |
OTTER PHARMS |
Labeling |
Approval |
| 02/05/2021 |
CLONAZEPAM
ANDA #211033 |
SUPPL-5 |
CLONAZEPAM |
ALEMBIC |
Labeling |
Approval |
| 02/05/2021 |
NAYZILAM
NDA #211321 |
SUPPL-5 |
MIDAZOLAM |
UCB INC |
Labeling |
Approval |
| 02/05/2021 |
VALTOCO
NDA #211635 |
SUPPL-3 |
DIAZEPAM |
NEURELIS INC |
Labeling |
Approval |
| 02/05/2021 |
TRIAMCINOLONE ACETONIDE
ANDA #212460 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
PADAGIS ISRAEL |
|
Approval |
| 02/05/2021 |
UKONIQ
NDA #213176 |
ORIG-1 |
UMBRALISIB TOSYLATE |
TG THERAPS |
Type 1 - New Molecular Entity |
Approval |
| 02/05/2021 |
UKONIQ
NDA #213176 |
ORIG-2 |
UMBRALISIB TOSYLATE |
TG THERAPS |
Efficacy |
Approval |
| 02/05/2021 |
FLUOCINOLONE ACETONIDE
ANDA #213264 |
ORIG-1 |
FLUOCINOLONE ACETONIDE |
TRUPHARMA |
|
Approval |
| 02/05/2021 |
POTASSIUM CITRATE
ANDA #214420 |
ORIG-1 |
POTASSIUM CITRATE |
ASCENT PHARMS INC |
|
Approval |
| 02/06/2021 |
PAXIL
NDA #020031 |
SUPPL-77 |
PAROXETINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 02/06/2021 |
PAXIL
NDA #020710 |
SUPPL-45 |
PAROXETINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 02/08/2021 |
DIAZEPAM
ANDA #070311 |
SUPPL-20 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #070345 |
SUPPL-23 |
FLURAZEPAM HYDROCHLORIDE |
RISING PHARMA |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #070444 |
SUPPL-14 |
FLURAZEPAM HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #070445 |
SUPPL-14 |
FLURAZEPAM HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #070454 |
SUPPL-20 |
FLURAZEPAM HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #070455 |
SUPPL-20 |
FLURAZEPAM HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #071068 |
SUPPL-17 |
FLURAZEPAM HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #071107 |
SUPPL-31 |
FLURAZEPAM HYDROCHLORIDE |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #071108 |
SUPPL-30 |
FLURAZEPAM HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #071205 |
SUPPL-17 |
FLURAZEPAM HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #072368 |
SUPPL-7 |
FLURAZEPAM HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/08/2021 |
FLURAZEPAM HYDROCHLORIDE
ANDA #072369 |
SUPPL-7 |
FLURAZEPAM HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/08/2021 |
DIAZEPAM
ANDA #072370 |
SUPPL-7 |
DIAZEPAM |
WATSON LABS INC |
Labeling |
Approval |
| 02/08/2021 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #078633 |
SUPPL-20 |
BUPRENORPHINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 02/08/2021 |
IRBESARTAN
ANDA #090201 |
SUPPL-6 |
IRBESARTAN |
HIKMA |
Labeling |
Approval |
| 02/08/2021 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090819 |
SUPPL-18 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 02/08/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #090964 |
SUPPL-5 |
OXYMORPHONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 02/08/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #090964 |
SUPPL-7 |
OXYMORPHONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 02/08/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #090964 |
SUPPL-8 |
OXYMORPHONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 02/08/2021 |
LEVOFLOXACIN
ANDA #202200 |
SUPPL-9 |
LEVOFLOXACIN |
ORBION PHARMS |
Labeling |
Approval |
| 02/08/2021 |
LEVOFLOXACIN
ANDA #202200 |
SUPPL-10 |
LEVOFLOXACIN |
ORBION PHARMS |
Labeling |
Approval |
| 02/08/2021 |
METHADONE HYDROCHLORIDE
ANDA #207537 |
SUPPL-1 |
METHADONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 02/08/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #210175 |
SUPPL-3 |
OXYMORPHONE HYDROCHLORIDE |
ASCENT PHARMS INC |
Labeling |
Approval |
| 02/08/2021 |
DIAZEPAM
ANDA #210363 |
SUPPL-4 |
DIAZEPAM |
BELOTECA |
Labeling |
Approval |
| 02/08/2021 |
DIAZEPAM
ANDA #211998 |
SUPPL-2 |
DIAZEPAM |
BELOTECA |
Labeling |
Approval |
| 02/08/2021 |
TAVABOROLE
ANDA #212168 |
ORIG-1 |
TAVABOROLE |
LUPIN LTD |
|
Approval |
| 02/08/2021 |
CLOBETASOL PROPIONATE
ANDA #213139 |
ORIG-1 |
CLOBETASOL PROPIONATE |
PRINSTON INC |
|
Approval |
| 02/08/2021 |
DARZALEX FASPRO
BLA #761145 |
SUPPL-8 |
DARATUMUMAB;HYALURONIDASE-FIHJ |
JANSSEN BIOTECH |
|
Approval |
| 02/09/2021 |
DROXIA
NDA #016295 |
SUPPL-54 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 02/09/2021 |
HYDREA
NDA #016295 |
SUPPL-54 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 02/09/2021 |
BUSPIRONE HYDROCHLORIDE
ANDA #076008 |
SUPPL-14 |
BUSPIRONE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 02/09/2021 |
FLUOXETINE HYDROCHLORIDE
ANDA #078143 |
SUPPL-3 |
FLUOXETINE HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
| 02/09/2021 |
FLUOXETINE HYDROCHLORIDE
ANDA #078143 |
SUPPL-4 |
FLUOXETINE HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
| 02/09/2021 |
CARBIDOPA AND LEVODOPA
ANDA #078536 |
SUPPL-23 |
CARBIDOPA; LEVODOPA |
SUN PHARM INDS |
Labeling |
Approval |
| 02/09/2021 |
CLINDAMYCIN PHOSPHATE
ANDA #090109 |
SUPPL-13 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/09/2021 |
CLINDAMYCIN PHOSPHATE
ANDA #090109 |
SUPPL-15 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/09/2021 |
CLINDAMYCIN PHOSPHATE
ANDA #090109 |
SUPPL-16 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/09/2021 |
BOTOX
BLA #103000 |
SUPPL-5318 |
OnabotulinumtoxinA |
ALLERGAN |
|
Approval |
| 02/09/2021 |
BOTOX COSMETIC
BLA #103000 |
SUPPL-5318 |
OnabotulinumtoxinA |
ALLERGAN |
|
Approval |
| 02/09/2021 |
FINGOLIMOD HYDROCHLORIDE
ANDA #207979 |
SUPPL-2 |
FINGOLIMOD HYDROCHLORIDE |
BIOCON LTD |
Labeling |
Approval |
| 02/09/2021 |
AUSTEDO
NDA #208082 |
SUPPL-8 |
DEUTETRABENAZINE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 02/09/2021 |
TOBRAMYCIN SULFATE (PHARMACY BULK)
ANDA #209346 |
ORIG-1 |
TOBRAMYCIN SULFATE |
GLAND PHARMA LTD |
|
Approval |
| 02/09/2021 |
LINACLOTIDE
ANDA #209564 |
ORIG-1 |
LINACLOTIDE |
MYLAN |
|
Approval |
| 02/09/2021 |
ISOPROTERENOL HYDROCHLORIDE
ANDA #211864 |
ORIG-1 |
ISOPROTERENOL HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
| 02/09/2021 |
TAVABOROLE
ANDA #212224 |
ORIG-1 |
TAVABOROLE |
CIPLA |
|
Approval |
| 02/09/2021 |
DEFERASIROX
ANDA #214194 |
ORIG-1 |
DEFERASIROX |
AMNEAL |
|
Approval |
| 02/09/2021 |
LIBTAYO
BLA #761097 |
SUPPL-8 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
| 02/09/2021 |
LIBTAYO
BLA #761097 |
SUPPL-9 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
| 02/09/2021 |
ZIRABEV
BLA #761099 |
SUPPL-4 |
BEVACIZUMAB-BVZR |
PFIZER INC |
|
Approval |
| 02/09/2021 |
ZIRABEV
BLA #761099 |
SUPPL-6 |
BEVACIZUMAB-BVZR |
PFIZER INC |
|
Approval |
| 02/10/2021 |
DEPAKOTE
NDA #018723 |
SUPPL-64 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 02/10/2021 |
DEPAKOTE
NDA #019680 |
SUPPL-51 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 02/10/2021 |
DEPAKOTE ER
NDA #021168 |
SUPPL-42 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 02/10/2021 |
IDAMYCIN
NDA #050661 |
SUPPL-16 |
IDARUBICIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 02/10/2021 |
IDAMYCIN PFS
NDA #050734 |
SUPPL-27 |
IDARUBICIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 02/10/2021 |
NPLATE
BLA #125268 |
SUPPL-168 |
ROMIPLOSTIM |
AMGEN |
|
Approval |
| 02/10/2021 |
KEYTRUDA
BLA #125514 |
SUPPL-98 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 02/10/2021 |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #202054 |
SUPPL-2 |
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
INDOCO |
Labeling |
Approval |
| 02/10/2021 |
FENOFIBRATE
ANDA #208476 |
ORIG-1 |
FENOFIBRATE |
AUSTARPHARMA |
|
Approval |
| 02/10/2021 |
TRULANCE
NDA #208745 |
SUPPL-7 |
PLECANATIDE |
SALIX |
Labeling |
Approval |
| 02/10/2021 |
YARGESA
ANDA #209821 |
SUPPL-1 |
MIGLUSTAT |
EDENBRIDGE PHARMS |
Labeling |
Approval |
| 02/10/2021 |
STERILE WATER FOR INJECTION
ANDA #211222 |
ORIG-1 |
STERILE WATER FOR INJECTION |
NEPHRON |
|
Approval |
| 02/10/2021 |
LOTEPREDNOL ETABONATE
ANDA #212080 |
ORIG-1 |
LOTEPREDNOL ETABONATE |
SENTISS |
|
Approval |
| 02/10/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #212616 |
ORIG-1 |
MOXIFLOXACIN HYDROCHLORIDE |
UPSHER SMITH LABS |
|
Approval |
| 02/10/2021 |
CLINDAMYCIN PHOSPHATE
ANDA #214251 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
GLENMARK PHARMS LTD |
|
Approval |
| 02/10/2021 |
MYCOPHENOLIC SODIUM
ANDA #214376 |
ORIG-1 |
MYCOPHENOLIC SODIUM |
AMTA |
|
Approval |
| 02/11/2021 |
DEPO-MEDROL
NDA #011757 |
SUPPL-119 |
METHYLPREDNISOLONE ACETATE |
PFIZER |
Labeling |
Approval |
| 02/11/2021 |
CLOZARIL
NDA #019758 |
SUPPL-88 |
CLOZAPINE |
HERITAGE LIFE |
Labeling |
Approval |
| 02/11/2021 |
XYREM
NDA #021196 |
SUPPL-35 |
SODIUM OXYBATE |
JAZZ PHARMS |
REMS |
Approval |
| 02/11/2021 |
VANDAZOLE
NDA #021806 |
SUPPL-8 |
METRONIDAZOLE |
TEVA PHARMS |
Labeling |
Approval |
| 02/11/2021 |
PRAVASTATIN SODIUM
ANDA #077793 |
SUPPL-13 |
PRAVASTATIN SODIUM |
TEVA PHARMS |
Labeling |
Approval |
| 02/11/2021 |
CLINDAMYCIN PHOSPHATE
ANDA #090108 |
SUPPL-11 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/11/2021 |
CLINDAMYCIN PHOSPHATE
ANDA #090108 |
SUPPL-13 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/11/2021 |
CLINDAMYCIN PHOSPHATE
ANDA #090108 |
SUPPL-15 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/11/2021 |
LEVOFLOXACIN
ANDA #090367 |
SUPPL-5 |
LEVOFLOXACIN |
CELLTRION |
Labeling |
Approval |
| 02/11/2021 |
NAFCILLIN SODIUM
ANDA #090582 |
SUPPL-1 |
NAFCILLIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 02/11/2021 |
NAFCILLIN SODIUM
ANDA #090582 |
SUPPL-3 |
NAFCILLIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 02/11/2021 |
NAFCILLIN SODIUM
ANDA #090582 |
SUPPL-5 |
NAFCILLIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 02/11/2021 |
LEVOFLOXACIN
ANDA #090787 |
SUPPL-13 |
LEVOFLOXACIN |
APOTEX INC |
Labeling |
Approval |
| 02/11/2021 |
NAFCILLIN SODIUM
ANDA #091613 |
SUPPL-3 |
NAFCILLIN SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 02/11/2021 |
NAFCILLIN SODIUM
ANDA #091613 |
SUPPL-6 |
NAFCILLIN SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 02/11/2021 |
GATTEX KIT
NDA #203441 |
SUPPL-20 |
TEDUGLUTIDE |
TAKEDA PHARMS USA |
REMS |
Approval |
| 02/11/2021 |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #204842 |
ORIG-1 |
BUPIVACAINE HYDROCHLORIDE |
HIKMA PHARMS |
|
Approval |
| 02/11/2021 |
BUPIVACAINE HYDROCHLORIDE
ANDA #205141 |
ORIG-1 |
BUPIVACAINE HYDROCHLORIDE |
HIKMA PHARMS |
|
Approval |
| 02/11/2021 |
TADALAFIL
ANDA #207290 |
SUPPL-4 |
TADALAFIL |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 02/11/2021 |
LAMOTRIGINE
ANDA #207497 |
SUPPL-11 |
LAMOTRIGINE |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/11/2021 |
PARSABIV
NDA #208325 |
SUPPL-5 |
ETELCALCETIDE |
KAI PHARMS INC |
Labeling |
Approval |
| 02/11/2021 |
PREDNISONE
ANDA #208412 |
ORIG-1 |
PREDNISONE |
STRIDES PHARMA |
|
Approval |
| 02/11/2021 |
TOBRAMYCIN SULFATE
ANDA #209621 |
ORIG-1 |
TOBRAMYCIN SULFATE |
GLAND PHARMA LTD |
|
Approval |
| 02/11/2021 |
TADALAFIL
ANDA #210145 |
SUPPL-2 |
TADALAFIL |
DR REDDYS |
Labeling |
Approval |
| 02/11/2021 |
BIKTARVY
NDA #210251 |
SUPPL-9 |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 02/11/2021 |
SUCCINYLCHOLINE CHLORIDE
ANDA #210698 |
SUPPL-6 |
SUCCINYLCHOLINE CHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/11/2021 |
GLOPERBA
NDA #210942 |
SUPPL-1 |
COLCHICINE |
SCILEX PHARMS |
Manufacturing (CMC) |
Approval |
| 02/11/2021 |
TREPROSTINIL
ANDA #211574 |
ORIG-1 |
TREPROSTINIL |
ALEMBIC GLOBAL |
|
Approval |
| 02/11/2021 |
VYONDYS 53
NDA #211970 |
SUPPL-2 |
GOLODIRSEN |
SAREPTA THERAPS INC |
Labeling |
Approval |
| 02/11/2021 |
DULOXETINE HYDROCHLORIDE
ANDA #212328 |
ORIG-1 |
DULOXETINE HYDROCHLORIDE |
SUNSHINE |
|
Approval |
| 02/11/2021 |
XYWAV
NDA #212690 |
SUPPL-1 |
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE |
JAZZ |
Labeling |
Approval |
| 02/11/2021 |
XYWAV
NDA #212690 |
SUPPL-2 |
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE |
JAZZ |
REMS |
Approval |
| 02/11/2021 |
HYDROCORTISONE VALERATE
ANDA #213724 |
ORIG-1 |
HYDROCORTISONE VALERATE |
COSETTE |
|
Approval |
| 02/11/2021 |
EVEROLIMUS
ANDA #214182 |
ORIG-1 |
EVEROLIMUS |
BIOCON PHARMA |
|
Approval |
| 02/11/2021 |
ERYTHROMYCIN
ANDA #214549 |
ORIG-1 |
ERYTHROMYCIN |
TEVA PHARMS USA INC |
|
Approval |
| 02/11/2021 |
EVKEEZA
BLA #761181 |
ORIG-1 |
EVINACUMAB-DGNB |
REGENERON PHARMACEUTICALS |
|
Approval |
| 02/12/2021 |
LUPRON DEPOT
NDA #019943 |
SUPPL-35 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
| 02/12/2021 |
LUPRON DEPOT
NDA #020011 |
SUPPL-42 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
| 02/12/2021 |
RISPERDAL
NDA #020272 |
SUPPL-83 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
RISPERDAL
NDA #020588 |
SUPPL-71 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
RISPERDAL CONSTA
NDA #021346 |
SUPPL-61 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
RISPERDAL
NDA #021444 |
SUPPL-57 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
INVEGA
NDA #021999 |
SUPPL-37 |
PALIPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
INVEGA SUSTENNA
NDA #022264 |
SUPPL-30 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
PENTOLAIR
ANDA #040075 |
SUPPL-25 |
CYCLOPENTOLATE HYDROCHLORIDE |
BAUSCH AND LOMB |
Labeling |
Approval |
| 02/12/2021 |
JEVTANA KIT
NDA #201023 |
SUPPL-25 |
CABAZITAXEL |
SANOFI AVENTIS US |
Labeling |
Approval |
| 02/12/2021 |
INVEGA HAFYERA
NDA #207946 |
SUPPL-9 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
INVEGA TRINZA
NDA #207946 |
SUPPL-9 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 02/12/2021 |
MORPHINE SULFATE
ANDA #211454 |
ORIG-1 |
MORPHINE SULFATE |
WINDER LABS LLC |
|
Approval |
| 02/12/2021 |
METOPROLOL SUCCINATE
ANDA #213854 |
ORIG-1 |
METOPROLOL SUCCINATE |
YICHANG HUMANWELL |
|
Approval |
| 02/12/2021 |
AMINOCAPROIC ACID
ANDA #213928 |
ORIG-1 |
AMINOCAPROIC ACID |
CARNEGIE |
|
Approval |
| 02/12/2021 |
COSELA
NDA #214200 |
ORIG-1 |
TRILACICLIB DIHYDROCHLORIDE |
G1 THERAP |
Type 1 - New Molecular Entity |
Approval |
| 02/16/2021 |
DILANTIN-125
NDA #008762 |
SUPPL-65 |
PHENYTOIN |
VIATRIS |
Labeling |
Approval |
| 02/16/2021 |
DILANTIN-30
NDA #008762 |
SUPPL-65 |
PHENYTOIN |
VIATRIS |
Labeling |
Approval |
| 02/16/2021 |
CEREBYX
NDA #020450 |
SUPPL-42 |
FOSPHENYTOIN SODIUM |
PARKE DAVIS |
Labeling |
Approval |
| 02/16/2021 |
ASMANEX TWISTHALER
NDA #021067 |
SUPPL-32 |
MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
| 02/16/2021 |
PHENYTOIN SODIUM
ANDA #040573 |
SUPPL-13 |
PHENYTOIN SODIUM |
ACELLA |
Labeling |
Approval |
| 02/16/2021 |
PHENYTOIN SODIUM
ANDA #040781 |
SUPPL-7 |
PHENYTOIN SODIUM |
AM REGENT |
Labeling |
Approval |
| 02/16/2021 |
SOTALOL HYDROCHLORIDE
ANDA #075663 |
SUPPL-3 |
SOTALOL HYDROCHLORIDE |
IMPAX PHARMS |
Labeling |
Approval |
| 02/16/2021 |
SOTALOL HYDROCHLORIDE
ANDA #075725 |
SUPPL-8 |
SOTALOL HYDROCHLORIDE |
RISING PHARMA |
Labeling |
Approval |
| 02/16/2021 |
PRAVASTATIN SODIUM
ANDA #076056 |
SUPPL-21 |
PRAVASTATIN SODIUM |
TEVA |
Labeling |
Approval |
| 02/16/2021 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-62 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #086183 |
SUPPL-39 |
HYDROXYZINE PAMOATE |
SANDOZ |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #086183 |
SUPPL-40 |
HYDROXYZINE PAMOATE |
SANDOZ |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #087479 |
SUPPL-40 |
HYDROXYZINE PAMOATE |
SANDOZ |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #087479 |
SUPPL-41 |
HYDROXYZINE PAMOATE |
SANDOZ |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #088487 |
SUPPL-53 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #088487 |
SUPPL-54 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #088488 |
SUPPL-51 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #088488 |
SUPPL-52 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #088496 |
SUPPL-51 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 02/16/2021 |
HYDROXYZINE PAMOATE
ANDA #088496 |
SUPPL-52 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 02/16/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #201187 |
SUPPL-2 |
OXYMORPHONE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/16/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #201187 |
SUPPL-5 |
OXYMORPHONE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/16/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #201187 |
SUPPL-7 |
OXYMORPHONE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/16/2021 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201760 |
SUPPL-15 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 02/16/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #204459 |
SUPPL-1 |
OXYMORPHONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/16/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #204459 |
SUPPL-3 |
OXYMORPHONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/16/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #204459 |
SUPPL-4 |
OXYMORPHONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/16/2021 |
LYPQOZET
ANDA #206084 |
SUPPL-2 |
ATORVASTATIN CALCIUM; EZETIMIBE |
ALTHERA PHARMS |
Labeling |
Approval |
| 02/16/2021 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000 |
SUPPL-7 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 02/16/2021 |
ENTRESTO
NDA #207620 |
SUPPL-18 |
SACUBITRIL; VALSARTAN |
NOVARTIS PHARMS CORP |
Efficacy |
Approval |
| 02/16/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #208674 |
ORIG-1 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SAGENT PHARMS INC |
|
Approval |
| 02/16/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #208675 |
ORIG-1 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SAGENT PHARMS INC |
|
Approval |
| 02/16/2021 |
METHADONE HYDROCHLORIDE
ANDA #210484 |
SUPPL-2 |
METHADONE HYDROCHLORIDE |
ELITE LABS INC |
Labeling |
Approval |
| 02/16/2021 |
METHADONE HYDROCHLORIDE
ANDA #210484 |
SUPPL-5 |
METHADONE HYDROCHLORIDE |
ELITE LABS INC |
Labeling |
Approval |
| 02/16/2021 |
ISOPROTERENOL HYDROCHLORIDE
ANDA #210845 |
ORIG-1 |
ISOPROTERENOL HYDROCHLORIDE |
MICRO LABS |
|
Approval |
| 02/16/2021 |
PAROXETINE HYDROCHLORIDE
ANDA #213485 |
ORIG-1 |
PAROXETINE HYDROCHLORIDE |
CSPC OUYI |
|
Approval |
| 02/16/2021 |
POTASSIUM CHLORIDE
ANDA #214686 |
ORIG-1 |
POTASSIUM CHLORIDE |
GRANULES |
|
Approval |
| 02/17/2021 |
TRIZIVIR
NDA #021205 |
SUPPL-41 |
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
| 02/17/2021 |
EPZICOM
NDA #021652 |
SUPPL-28 |
ABACAVIR SULFATE; LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
| 02/17/2021 |
BRILINTA
NDA #022433 |
SUPPL-31 |
TICAGRELOR |
ASTRAZENECA |
Labeling |
Approval |
| 02/17/2021 |
HALOPERIDOL
ANDA #071130 |
SUPPL-11 |
HALOPERIDOL |
SCIEGEN PHARMS INC |
Manufacturing (CMC) |
Approval |
| 02/17/2021 |
QUETIAPINE FUMARATE
ANDA #077380 |
SUPPL-6 |
QUETIAPINE FUMARATE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 02/17/2021 |
QUETIAPINE FUMARATE
ANDA #077380 |
SUPPL-7 |
QUETIAPINE FUMARATE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 02/17/2021 |
QUETIAPINE FUMARATE
ANDA #077380 |
SUPPL-8 |
QUETIAPINE FUMARATE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 02/17/2021 |
FOSPHENYTOIN SODIUM
ANDA #078476 |
SUPPL-13 |
FOSPHENYTOIN SODIUM |
AMNEAL |
Labeling |
Approval |
| 02/17/2021 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202970 |
SUPPL-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 02/17/2021 |
LAMIVUDINE
ANDA #204002 |
SUPPL-3 |
LAMIVUDINE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 02/17/2021 |
LAMIVUDINE
ANDA #204002 |
SUPPL-4 |
LAMIVUDINE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 02/17/2021 |
LAMIVUDINE
ANDA #204002 |
SUPPL-6 |
LAMIVUDINE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 02/17/2021 |
ESTRADIOL
ANDA #205256 |
SUPPL-2 |
ESTRADIOL |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/17/2021 |
ESTRADIOL
ANDA #205256 |
SUPPL-3 |
ESTRADIOL |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/17/2021 |
RISEDRONATE SODIUM
ANDA #205280 |
SUPPL-1 |
RISEDRONATE SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 02/17/2021 |
ESTRADIOL
ANDA #206388 |
SUPPL-3 |
ESTRADIOL |
TEVA PHARMS USA |
Labeling |
Approval |
| 02/17/2021 |
ESTRADIOL
ANDA #206388 |
SUPPL-5 |
ESTRADIOL |
TEVA PHARMS USA |
Labeling |
Approval |
| 02/17/2021 |
SUMATRIPTAN
ANDA #208967 |
ORIG-1 |
SUMATRIPTAN |
FLORIDA |
|
Approval |
| 02/17/2021 |
ESTRADIOL
ANDA #210264 |
SUPPL-1 |
ESTRADIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/17/2021 |
APREMILAST
ANDA #211819 |
ORIG-1 |
APREMILAST |
UNICHEM |
|
Approval |
| 02/17/2021 |
TECENTRIQ
BLA #761034 |
SUPPL-33 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 02/17/2021 |
TECENTRIQ
BLA #761034 |
SUPPL-34 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 02/17/2021 |
TECENTRIQ
BLA #761034 |
SUPPL-35 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 02/17/2021 |
TECENTRIQ
BLA #761034 |
SUPPL-36 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 02/17/2021 |
TECENTRIQ
BLA #761034 |
SUPPL-37 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 02/17/2021 |
TECENTRIQ
BLA #761034 |
SUPPL-38 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 02/18/2021 |
CLOZARIL
NDA #019758 |
SUPPL-96 |
CLOZAPINE |
HERITAGE LIFE |
REMS |
Approval |
| 02/18/2021 |
ELLENCE
NDA #050778 |
SUPPL-26 |
EPIRUBICIN HYDROCHLORIDE |
PFIZER INC |
Labeling |
Approval |
| 02/18/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065458 |
SUPPL-12 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
STERISCIENCE SPECLTS |
Labeling |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #074949 |
SUPPL-81 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
REMS |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #075417 |
SUPPL-46 |
CLOZAPINE |
MYLAN |
REMS |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #075713 |
SUPPL-50 |
CLOZAPINE |
SUN PHARM INDS INC |
REMS |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #076809 |
SUPPL-44 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
REMS |
Approval |
| 02/18/2021 |
FAMOTIDINE
ANDA #077351 |
SUPPL-23 |
FAMOTIDINE |
PERRIGO R AND D |
Labeling |
Approval |
| 02/18/2021 |
ATOMOXETINE HYDROCHLORIDE
ANDA #079021 |
ORIG-1 |
ATOMOXETINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #090308 |
SUPPL-8 |
CLOZAPINE |
BARR LABS INC |
REMS |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #201824 |
SUPPL-13 |
CLOZAPINE |
MYLAN |
REMS |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #202873 |
SUPPL-8 |
CLOZAPINE |
ACCORD HLTHCARE |
REMS |
Approval |
| 02/18/2021 |
VERSACLOZ
NDA #203479 |
SUPPL-15 |
CLOZAPINE |
TASMAN PHARMA |
REMS |
Approval |
| 02/18/2021 |
METHADONE HYDROCHLORIDE
ANDA #203502 |
SUPPL-4 |
METHADONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/18/2021 |
METHADONE HYDROCHLORIDE
ANDA #203502 |
SUPPL-7 |
METHADONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/18/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #203719 |
SUPPL-3 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
FRESENIUS KABI |
Labeling |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #203807 |
SUPPL-10 |
CLOZAPINE |
DR REDDYS LABS SA |
REMS |
Approval |
| 02/18/2021 |
ACETAMINOPHEN
NDA #204957 |
ORIG-1 |
ACETAMINOPHEN |
B BRAUN MEDICAL INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 02/18/2021 |
QUDEXY XR
NDA #205122 |
SUPPL-11 |
TOPIRAMATE |
UPSHER SMITH LABS |
Labeling |
Approval |
| 02/18/2021 |
CLOZAPINE
ANDA #206433 |
SUPPL-9 |
CLOZAPINE |
AUROBINDO PHARMA |
REMS |
Approval |
| 02/18/2021 |
METHADONE HYDROCHLORIDE
ANDA #207368 |
SUPPL-2 |
METHADONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 02/18/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #207847 |
SUPPL-8 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
PROVEPHARM SAS |
Labeling |
Approval |
| 02/18/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #207847 |
SUPPL-9 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
PROVEPHARM SAS |
Labeling |
Approval |
| 02/18/2021 |
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
NDA #208083 |
SUPPL-4 |
CLINDAMYCIN PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 02/18/2021 |
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
ANDA #208111 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE |
PADAGIS ISRAEL |
|
Approval |
| 02/18/2021 |
METHADONE HYDROCHLORIDE
ANDA #208305 |
SUPPL-4 |
METHADONE HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 02/18/2021 |
OLOPATADINE HYDROCHLORIDE
ANDA #209919 |
SUPPL-2 |
OLOPATADINE HYDROCHLORIDE |
ALEMBIC |
Labeling |
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #211652 |
ORIG-1 |
DROXIDOPA |
LUPIN PHARMS |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #211726 |
ORIG-1 |
DROXIDOPA |
ANNORA |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #211741 |
ORIG-1 |
DROXIDOPA |
MSN PHARMS INC |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #211818 |
ORIG-1 |
DROXIDOPA |
ZYDUS PHARMS |
|
Approval |
| 02/18/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #212287 |
SUPPL-4 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ASTRAL |
Labeling |
Approval |
| 02/18/2021 |
PIPERACILLIN AND TAZOBACTAM
ANDA #212287 |
SUPPL-5 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ASTRAL |
Labeling |
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #212835 |
ORIG-1 |
DROXIDOPA |
HIKMA |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #213162 |
ORIG-1 |
DROXIDOPA |
TEVA PHARMS USA INC |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #213661 |
ORIG-1 |
DROXIDOPA |
UPSHER SMITH LABS |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #213911 |
ORIG-1 |
DROXIDOPA |
ALKEM LABS LTD |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #214017 |
ORIG-1 |
DROXIDOPA |
SCIEGEN PHARMS INC |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #214384 |
ORIG-1 |
DROXIDOPA |
SUN PHARM |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #214387 |
ORIG-1 |
DROXIDOPA |
AUROBINDO PHARMA LTD |
|
Approval |
| 02/18/2021 |
DROXIDOPA
ANDA #214391 |
ORIG-1 |
DROXIDOPA |
AJANTA PHARMA LTD |
|
Approval |
| 02/19/2021 |
ALDACTAZIDE
NDA #012616 |
SUPPL-81 |
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
PFIZER |
Labeling |
Approval |
| 02/19/2021 |
ACCURETIC
NDA #020125 |
SUPPL-28 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
PFIZER PHARMS |
Labeling |
Approval |
| 02/19/2021 |
CHILDREN'S MOTRIN
NDA #020516 |
SUPPL-38 |
IBUPROFEN |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 02/19/2021 |
MUCINEX
NDA #021282 |
SUPPL-54 |
GUAIFENESIN |
RB HLTH |
Labeling |
Approval |
| 02/19/2021 |
MUCINEX DM
NDA #021620 |
SUPPL-43 |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
RB HLTH |
Labeling |
Approval |
| 02/19/2021 |
FAMOTIDINE
ANDA #075786 |
SUPPL-6 |
FAMOTIDINE |
CHARTWELL RX |
Labeling |
Approval |
| 02/19/2021 |
HALAVEN
NDA #201532 |
SUPPL-20 |
ERIBULIN MESYLATE |
EISAI INC |
Labeling |
Approval |
| 02/19/2021 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202126 |
SUPPL-5 |
DEXMEDETOMIDINE HYDROCHLORIDE |
GLAND |
Labeling |
Approval |
| 02/19/2021 |
LAMOTRIGINE
ANDA #203370 |
SUPPL-12 |
LAMOTRIGINE |
TORRENT |
Labeling |
Approval |
| 02/19/2021 |
OXYMORPHONE HYDROCHLORIDE
ANDA #203601 |
SUPPL-3 |
OXYMORPHONE HYDROCHLORIDE |
AVANTHI INC |
Labeling |
Approval |
| 02/19/2021 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022 |
SUPPL-9 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
| 02/19/2021 |
CEFDINIR
ANDA #210220 |
ORIG-1 |
CEFDINIR |
ALKEM LABS LTD |
|
Approval |
| 02/19/2021 |
CEFDINIR
ANDA #210534 |
ORIG-1 |
CEFDINIR |
ALKEM LABS LTD |
|
Approval |
| 02/19/2021 |
LINEZOLID
ANDA #210702 |
SUPPL-4 |
LINEZOLID |
CHARTWELL RX |
Labeling |
Approval |
| 02/19/2021 |
METHADONE HYDROCHLORIDE
ANDA #211228 |
SUPPL-1 |
METHADONE HYDROCHLORIDE |
ASCENT PHARMS INC |
Labeling |
Approval |
| 02/19/2021 |
CEFIXIME
ANDA #211775 |
ORIG-1 |
CEFIXIME |
ALKEM LABS LTD |
|
Approval |
| 02/19/2021 |
AMITRIPTYLINE HYDROCHLORIDE
ANDA #213999 |
ORIG-1 |
AMITRIPTYLINE HYDROCHLORIDE |
MANKIND PHARMA |
|
Approval |
| 02/19/2021 |
POTASSIUM CITRATE
ANDA #214426 |
ORIG-1 |
POTASSIUM CITRATE |
HIBROW HLTHCARE |
|
Approval |
| 02/19/2021 |
IMFINZI
BLA #761069 |
SUPPL-29 |
DURVALUMAB |
ASTRAZENECA UK LTD |
|
Approval |
| 02/22/2021 |
SINGULAIR
NDA #020829 |
SUPPL-74 |
MONTELUKAST SODIUM |
ORGANON |
Labeling |
Approval |
| 02/22/2021 |
SINGULAIR
NDA #020830 |
SUPPL-76 |
MONTELUKAST SODIUM |
ORGANON |
Labeling |
Approval |
| 02/22/2021 |
SINGULAIR
NDA #021409 |
SUPPL-52 |
MONTELUKAST SODIUM |
ORGANON |
Labeling |
Approval |
| 02/22/2021 |
EXFORGE HCT
NDA #022314 |
SUPPL-36 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
NOVARTIS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-2 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-3 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-6 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-7 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-8 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-9 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-10 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938 |
SUPPL-11 |
MOXIFLOXACIN HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 02/22/2021 |
SPIRONOLACTONE
ANDA #091426 |
SUPPL-17 |
SPIRONOLACTONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/22/2021 |
ACETAZOLAMIDE
ANDA #211372 |
ORIG-1 |
ACETAZOLAMIDE |
APPCO |
|
Approval |
| 02/22/2021 |
IBUPROFEN
ANDA #211666 |
ORIG-1 |
IBUPROFEN |
STRIDES PHARMA |
|
Approval |
| 02/22/2021 |
SUMATRIPTAN
ANDA #214209 |
ORIG-1 |
SUMATRIPTAN |
CIPLA |
|
Approval |
| 02/22/2021 |
VEKLURY
NDA #214787 |
SUPPL-5 |
REMDESIVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 02/22/2021 |
LIBTAYO
BLA #761097 |
SUPPL-7 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
| 02/23/2021 |
EZETIMIBE AND SIMVASTATIN
ANDA #201890 |
SUPPL-10 |
EZETIMIBE; SIMVASTATIN |
ANI PHARMS |
Labeling |
Approval |
| 02/23/2021 |
FLUDEOXYGLUCOSE F18
ANDA #204385 |
SUPPL-2 |
FLUDEOXYGLUCOSE F-18 |
CHILDRENS HOSP MI |
Labeling |
Approval |
| 02/23/2021 |
FYCOMPA
NDA #208277 |
SUPPL-5 |
PERAMPANEL |
CATALYST PHARMS |
Manufacturing (CMC) |
Approval |
| 02/23/2021 |
EZETIMIBE AND SIMVASTATIN
ANDA #209222 |
SUPPL-8 |
EZETIMIBE; SIMVASTATIN |
ALKEM LABS LTD |
Labeling |
Approval |
| 02/23/2021 |
EVEROLIMUS
ANDA #210130 |
SUPPL-2 |
EVEROLIMUS |
MYLAN |
Labeling |
Approval |
| 02/23/2021 |
RUFINAMIDE
ANDA #213410 |
ORIG-1 |
RUFINAMIDE |
ALKEM LABS LTD |
|
Approval |
| 02/23/2021 |
PEMAZYRE
NDA #213736 |
SUPPL-1 |
PEMIGATINIB |
INCYTE CORP |
Labeling |
Approval |
| 02/23/2021 |
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ANDA #214039 |
ORIG-1 |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
GRANULES |
|
Approval |
| 02/24/2021 |
AMPYRA
NDA #022250 |
SUPPL-18 |
DALFAMPRIDINE |
MERZ PHARMS GMBH |
Labeling |
Approval |
| 02/24/2021 |
HUMIRA
BLA #125057 |
SUPPL-417 |
ADALIMUMAB |
ABBVIE INC |
|
Approval |
| 02/24/2021 |
FLUDEOXYGLUCOSE F18
ANDA #204333 |
SUPPL-5 |
FLUDEOXYGLUCOSE F-18 |
MA GENERAL HOSP |
Labeling |
Approval |
| 02/24/2021 |
BIKTARVY
NDA #210251 |
SUPPL-8 |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 02/24/2021 |
SUCCINYLCHOLINE CHLORIDE
ANDA #211432 |
SUPPL-6 |
SUCCINYLCHOLINE CHLORIDE |
AMNEAL |
Labeling |
Approval |
| 02/24/2021 |
CYPROHEPTADINE HYDROCHLORIDE
ANDA #212491 |
ORIG-1 |
CYPROHEPTADINE HYDROCHLORIDE |
QUAGEN |
|
Approval |
| 02/24/2021 |
NALOXEGOL
ANDA #212625 |
ORIG-1 |
NALOXEGOL |
MSN LABS PVT LTD |
|
Tentative Approval |
| 02/24/2021 |
NORTRIPTYLINE HYDROCHLORIDE
ANDA #213441 |
ORIG-1 |
NORTRIPTYLINE HYDROCHLORIDE |
ZYDUS LIFESCIENCES |
|
Approval |
| 02/24/2021 |
HYRIMOZ
BLA #761071 |
SUPPL-1 |
ADALIMUMAB-ADAZ |
SANDOZ INC |
|
Approval |
| 02/25/2021 |
THALOMID
NDA #020785 |
SUPPL-69 |
THALIDOMIDE |
BRISTOL-MYERS |
Labeling |
Approval |
| 02/25/2021 |
OLOPATADINE HYDROCHLORIDE
ANDA #090848 |
SUPPL-9 |
OLOPATADINE HYDROCHLORIDE |
BARR LABS INC |
Labeling |
Approval |
| 02/25/2021 |
LINAGLIPTIN
ANDA #208428 |
ORIG-1 |
LINAGLIPTIN |
DR REDDYS LABS LTD |
|
Tentative Approval |
| 02/25/2021 |
AMONDYS 45
NDA #213026 |
ORIG-1 |
CASIMERSEN |
SAREPTA THERAPS INC |
Type 1 - New Molecular Entity |
Approval |
| 02/25/2021 |
ETHINYL ESTRADIOL AND NORELGESTROMIN
ANDA #213950 |
ORIG-1 |
ETHINYL ESTRADIOL; NORELGESTROMIN |
AMNEAL |
|
Approval |
| 02/26/2021 |
SPIRONOLACTONE
ANDA #040424 |
SUPPL-30 |
SPIRONOLACTONE |
MYLAN |
Labeling |
Approval |
| 02/26/2021 |
SPIRONOLACTONE
ANDA #040750 |
SUPPL-26 |
SPIRONOLACTONE |
OXFORD PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-6 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-7 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-9 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-10 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-11 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-12 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-13 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-16 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528 |
SUPPL-18 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OXYCODONE AND ASPIRIN
ANDA #091670 |
SUPPL-6 |
ASPIRIN; OXYCODONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 02/26/2021 |
ENBREL
BLA #103795 |
SUPPL-5582 |
ETANERCEPT |
IMMUNEX |
|
Approval |
| 02/26/2021 |
REPATHA
BLA #125522 |
ORIG-2 |
EVOLOCUMAB |
AMGEN INC |
|
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-4 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-6 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-7 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-8 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-9 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-10 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-11 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-15 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074 |
SUPPL-17 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 02/26/2021 |
SPIRONOLACTONE
ANDA #203512 |
SUPPL-5 |
SPIRONOLACTONE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 02/26/2021 |
POTASSIUM CHLORIDE
ANDA #203562 |
SUPPL-2 |
POTASSIUM CHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/26/2021 |
POTASSIUM CHLORIDE
ANDA #203562 |
SUPPL-3 |
POTASSIUM CHLORIDE |
GLENMARK PHARMS LTD |
Manufacturing (CMC) |
Approval |
| 02/26/2021 |
NOREPINEPHRINE BITARTRATE
ANDA #203662 |
SUPPL-3 |
NOREPINEPHRINE BITARTRATE |
HIKMA |
Labeling |
Approval |
| 02/26/2021 |
NOREPINEPHRINE BITARTRATE
ANDA #203662 |
SUPPL-4 |
NOREPINEPHRINE BITARTRATE |
HIKMA |
Labeling |
Approval |
| 02/26/2021 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #204278 |
SUPPL-13 |
HYDROMORPHONE HYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 02/26/2021 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #204278 |
SUPPL-14 |
HYDROMORPHONE HYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 02/26/2021 |
ESOMEPRAZOLE MAGNESIUM
ANDA #210559 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
INDCHEMIE HEALTH |
|
Approval |
| 02/26/2021 |
LORBRENA
NDA #210868 |
SUPPL-3 |
LORLATINIB |
PFIZER |
Labeling |
Approval |
| 02/26/2021 |
DAPAGLIFLOZIN
ANDA #211478 |
ORIG-1 |
DAPAGLIFLOZIN |
MSN LABORATORIES PRIVATE LTD |
|
Tentative Approval |
| 02/26/2021 |
LOTEPREDNOL ETABONATE
ANDA #212450 |
ORIG-1 |
LOTEPREDNOL ETABONATE |
SUN PHARM |
|
Approval |
| 02/26/2021 |
NULIBRY
NDA #214018 |
ORIG-1 |
FOSDENOPTERIN HYDROBROMIDE |
SENTYNL THERAPS INC |
Type 1 - New Molecular Entity |
Approval |
| 02/28/2021 |
INTEGRILIN
NDA #020718 |
SUPPL-39 |
EPTIFIBATIDE |
MSD SUB MERCK |
Labeling |
Approval |
