enforcement database
FDA ANDA Approvals
157 documented actions on record. Abbreviated New Drug Application approvals -- generic drug approvals granted by the FDA.
- Total actions
- 157
- Earliest on record
- June 9, 2026
- Most recent
- August 31, 2026
- Source
- openFDA (approval)
Severity breakdown
- Informational157
Most recent anda approvals (30 of 157 shown)
- DR REDDYS — ANDA approval: POMALIDOMIDE (unspecified)
August 31, 2026·Informational
- MACLEODS PHARMS LTD — ANDA approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE (unspecified)
August 31, 2026·Informational
- CIPLA — ANDA approval: POMALIDOMIDE (unspecified)
August 31, 2026·Informational
- SPIL — ANDA approval: POMALIDOMIDE (unspecified)
August 31, 2026·Informational
- SANDOZ — ANDA approval: POMALIDOMIDE (unspecified)
August 31, 2026·Informational
- QILU PHARM HAINAN — ANDA approval: DIFELIKEFALIN ACETATE (unspecified)
August 31, 2026·Informational
- MILLA PHARMS — ANDA approval: CALCIUM GLUCONATE IN SODIUM CHLORIDE (unspecified)
August 28, 2026·Informational
- ORBICULAR PHARM TECH — ANDA approval: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (unspecified)
August 27, 2026·Informational
- NATCO — ANDA approval: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (unspecified)
August 26, 2026·Informational
- ZYDUS LIFESCIENCES — ANDA approval: RIFABUTIN (unspecified)
August 21, 2026·Informational
- SOCORRO N1 — ANDA approval: NITROGLYCERIN (unspecified)
August 21, 2026·Informational
- ZYDUS PHARMS — ANDA approval: ASCORBIC ACID (unspecified)
August 20, 2026·Informational
- LAURUS — ANDA approval: TICAGRELOR (unspecified)
August 20, 2026·Informational
- ANNORA PHARMA — ANDA approval: LISINOPRIL (unspecified)
August 20, 2026·Informational
- BIOCON PHARMA — ANDA approval: NINTEDANIB ESYLATE (unspecified)
August 19, 2026·Informational
- EPIC PHARMA LLC — ANDA approval: RIVAROXABAN (unspecified)
August 19, 2026·Informational
- GLENMARK PHARMS LTD — ANDA approval: FLUTICASONE PROPIONATE (unspecified)
August 18, 2026·Informational
- STERINOVA INC — ANDA approval: NALOXONE HYDROCHLORIDE (unspecified)
August 18, 2026·Informational
- JUBILANT GENERICS — ANDA approval: TADALAFIL (unspecified)
August 17, 2026·Informational
- TEVA PHARMS USA — ANDA approval: TOFACITINIB CITRATE (unspecified)
August 17, 2026·Informational
- LUPIN LIMITED — ANDA approval: PITOLISANT (unspecified)
August 14, 2026·Informational
- MSN — ANDA approval: CABOZANTINIB S-MALATE (unspecified)
August 14, 2026·Informational
- CREEKWOOD PHARMS — ANDA approval: PROPRANOLOL HYDROCHLORIDE (unspecified)
August 14, 2026·Informational
- MSN LABORATORIES PRIVATE LTD — ANDA approval: PITOLISANT (unspecified)
August 14, 2026·Informational
- SANDOZ — ANDA approval: FIDAXOMICIN (unspecified)
August 13, 2026·Informational
- NOVITIUM PHARMA — ANDA approval: FOSFOMYCIN TROMETHAMINE (unspecified)
August 12, 2026·Informational
- AUROBINDO PHARMA LTD — ANDA approval: TRIAMCINOLONE ACETONIDE (unspecified)
August 11, 2026·Informational
- HUAREN PHARMACEUTICAL CO LTD — ANDA approval: VALSARTAN (unspecified)
August 11, 2026·Informational
- AUROBINDO PHARMA — ANDA approval: BRIVARACETAM (unspecified)
August 10, 2026·Informational
- VIWIT PHARM — ANDA approval: GADOTERATE MEGLUMINE (unspecified)
August 10, 2026·Informational
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.