FDA DRUG INTELLIGENCE

FDA Drug Approvals & Applications

Every drug FDA has approved or has under application — brand and generic name, the sponsor, dosage form and route, the full approval history, and current marketing status. Drawn from Drugs@FDA, each record links to live shortage and recall signals. Every value is FDA's own application data.

25,500 applications · 5,120 NDA · 19,972 ANDA · 408 BLA

NDA5,120

New Drug Application — a brand/innovator drug approved on its own safety and efficacy data.

ANDA19,972

Abbreviated New Drug Application — a generic shown to be bioequivalent to an approved reference drug.

BLA408

Biologics License Application — a biologic (vaccine, antibody, cell/gene therapy) licensed under the PHS Act.

Recently approved

The most recent FDA approval actions across all application types.

MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil hydrochloride
BPI LABS · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
STRIDES PHARMA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
HETERO LABS LTD V · 2026-07-29
ANDA090762ANDA
JUBILANT CADISTA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
PH HEALTH · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
STRIDES PHARMA INTL · 2026-07-29
ANDA076444ANDA
BARR · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenolic acid
BIOCON PHARMA · 2026-07-29
ANDA065520ANDA
MYLAN · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenolic acid
FOSUN WANBANG · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
HETERO LABS LTD V · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenolic acid
TWI PHARMS · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
AUROBINDO PHARMA · 2026-07-29
ONDANSETRONANDA
ondansetron hydrochloride
FRESENIUS KABI USA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
QUAGEN · 2026-07-29
ONDANSETRONANDA
ondansetron hydrochloride
FRESENIUS KABI USA · 2026-07-29
ANDA211272ANDA
TEVA PHARMS USA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
STRIDES PHARMA · 2026-07-29
ANDA204473ANDA
ZYDUS PHARMS · 2026-07-29
ANDA065521ANDA
MYLAN · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
TEVA PHARMS · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenolic acid
BIOCON PHARMA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
ALKEM LABS LTD · 2026-07-29
ANDA202720ANDA
TEVA PHARMS USA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
SANDOZ · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
MYLAN LABS LTD · 2026-07-29
ANDA090661ANDA
JUBILANT CADISTA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
AMNEAL · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
ALKEM LABS LTD · 2026-07-29
ANDA090606ANDA
AMNEAL · 2026-07-29
ANDA204076ANDA
ZHEJIANG HISUN PHARM · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenolic acid
APOTEX INC · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenolic acid
ALKEM LABS LTD · 2026-07-29
ANDA077124ANDA
SUN PHARM INDUSTRIES · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
MEITHEAL · 2026-07-29
LACOSAMIDEANDA
lacosamide
MSN LABS PVT LTD · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
AUROBINDO PHARMA LTD · 2026-07-29
ANDA065457ANDA
TEVA PHARMS · 2026-07-29
ANDA204077ANDA
ZHEJIANG HISUN PHARM · 2026-07-29
ANDA065410ANDA
HIKMA · 2026-07-29
ANDA217505ANDA
LNK INTL INC · 2026-07-29
CELLCEPTNDA
mycophenolate mofetil hydrochloride
ROCHE PALO · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
WUXI · 2026-07-29
MYHIBBINNDA
mycophenolate mofetil
AZURITY · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
ACCORD HLTHCARE · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
ALKEM LABS LTD · 2026-07-29
MYFORTICNDA
mycophenolic acid
NOVARTIS · 2026-07-29
NDA221094NDA
CMP DEV LLC · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
CONCORD BIOTECH LTD · 2026-07-29
VEKLURYNDA
remdesivir
GILEAD SCIENCES INC · 2026-07-29
NDA217379NDA
FLEX PHARMA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
HIKMA · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
AUROBINDO PHARMA LTD · 2026-07-29
ANDA076038ANDA
SUN PHARM INDUSTRIES · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenilic acid
RK PHARMA · 2026-07-29
MYCOPHENOLIC ACIDANDA
mycophenolic acid
CONCORD BIOTECH LTD · 2026-07-29
MYCOPHENOLATE MOFETILANDA
mycophenolate mofetil
ACCORD HLTHCARE · 2026-07-29
CELLCEPTNDA
mycophenolate mofetil
ROCHE PALO · 2026-07-29
ANDA204043ANDA
RISING · 2026-07-29
ANDA090111ANDA
STRIDES PHARMA INTL · 2026-07-29
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