enforcement database
FDA ANDA Approvals
80 documented actions on record. Abbreviated New Drug Application approvals -- generic drug approvals granted by the FDA.
- Total actions
- 80
- Earliest on record
- June 9, 2026
- Most recent
- July 21, 2026
- Source
- openFDA (approval)
Severity breakdown
- Informational80
Most recent anda approvals (30 of 80 shown)
- NOVITIUM PHARMA — ANDA approval: PITOLISANT HYDROCHLORIDE (unspecified)
July 21, 2026·Informational
- MSN — ANDA approval: CARFILZOMIB (unspecified)
July 20, 2026·Informational
- RUBICON RESEARCH — ANDA approval: DICYCLOMINE HYDROCHLORIDE (unspecified)
July 17, 2026·Informational
- RISING — ANDA approval: HYDROCORTISONE (unspecified)
July 16, 2026·Informational
- AUROBINDO PHARMA LTD — ANDA approval: ETODOLAC (unspecified)
July 15, 2026·Informational
- HETERO LABS LTD V — ANDA approval: AFATINIB DIMALEATE (unspecified)
July 14, 2026·Informational
- APOTEX — ANDA approval: AFATINIB DIMALEATE (unspecified)
July 14, 2026·Informational
- ANTHEA PHARMA — ANDA approval: PROPOFOL (unspecified)
July 14, 2026·Informational
- SHANDONG — ANDA approval: BRIVARACETAM (unspecified)
July 13, 2026·Informational
- UNICHEM — ANDA approval: ALPRAZOLAM (unspecified)
July 13, 2026·Informational
- TEVA PHARMS USA — ANDA approval: ELTROMBOPAG OLAMINE (unspecified)
July 13, 2026·Informational
- LAURUS — ANDA approval: RILPIVIRINE HYDROCHLORIDE (unspecified)
July 10, 2026·Informational
- BELOTECA — ANDA approval: ILOPROST (unspecified)
July 10, 2026·Informational
- GLENMARK PHARMS LTD — ANDA approval: NINTEDANIB (unspecified)
July 9, 2026·Informational
- HUMANWELL PURACAP — ANDA approval: NINTEDANIB ESYLATE (unspecified)
July 9, 2026·Informational
- SQUARE PHARMS PLC — ANDA approval: MAGNESIUM SULFATE (unspecified)
July 9, 2026·Informational
- MACLEODS PHARMS LTD — ANDA approval: DAPSONE (unspecified)
July 8, 2026·Informational
- BAXTER HLTHCARE CORP — ANDA approval: EPHEDRINE SULFATE (unspecified)
July 8, 2026·Informational
- ASPIRO — ANDA approval: CYANOCOBALAMIN (unspecified)
July 8, 2026·Informational
- STIRA — ANDA approval: DIMETHYL SULFOXIDE (unspecified)
July 7, 2026·Informational
- QUAGEN — ANDA approval: MORPHINE SULFATE (unspecified)
July 7, 2026·Informational
- ANNORA PHARMA — ANDA approval: DESOGESTREL AND ETHINYL ESTRADIOL (unspecified)
July 7, 2026·Informational
- SOMERSET THERAPS LLC — ANDA approval: VARENICLINE TARTRATE (unspecified)
July 6, 2026·Informational
- PADAGIS ISRAEL — ANDA approval: NITROGLYCERIN (unspecified)
July 6, 2026·Informational
- MILLA PHARMS — ANDA approval: SODIUM BICARBONATE (unspecified)
July 6, 2026·Informational
- BAXTER HLTHCARE CORP — ANDA approval: LEVOCARNITINE (unspecified)
July 2, 2026·Informational
- MACLEODS PHARMS LTD — ANDA approval: CHLORTHALIDONE (unspecified)
July 1, 2026·Informational
- MANKIND PHARMA — ANDA approval: RIVAROXABAN (unspecified)
July 1, 2026·Informational
- SABA ILAC SANAYIVE — ANDA approval: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (unspecified)
July 1, 2026·Informational
- SCIEGEN PHARMS — ANDA approval: BRIVARACETAM (unspecified)
July 1, 2026·Informational
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.