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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 2025

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on October 03, 2025.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2025 DIAMOX
NDA #008943		 SUPPL-54 ACETAZOLAMIDE TEVA BRANDED PHARM Labeling Approval
10/01/2025 ANTARA (MICRONIZED)
NDA #021695		 SUPPL-29 FENOFIBRATE LUPIN Labeling Approval
10/01/2025 MORPHINE SULFATE
ANDA #079040		 SUPPL-29 MORPHINE SULFATE ACTAVIS ELIZABETH Labeling Approval
10/01/2025 PANTOPRAZOLE SODIUM
ANDA #090296		 SUPPL-11 PANTOPRAZOLE SODIUM SANDOZ Labeling Approval
10/01/2025 PANTOPRAZOLE SODIUM
ANDA #090296		 SUPPL-12 PANTOPRAZOLE SODIUM SANDOZ Labeling Approval
10/01/2025 PANTOPRAZOLE SODIUM
ANDA #090296		 SUPPL-13 PANTOPRAZOLE SODIUM SANDOZ Labeling Approval
10/01/2025 LETROZOLE
ANDA #090934		 SUPPL-17 LETROZOLE ACCORD HLTHCARE Labeling Approval
10/01/2025 LETROZOLE
ANDA #090934		 SUPPL-18 LETROZOLE ACCORD HLTHCARE Labeling Approval
10/01/2025 SIMPONI
BLA #125289		 SUPPL-156 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
10/01/2025 FLUOCINOLONE ACETONIDE
ANDA #202848		 SUPPL-14 FLUOCINOLONE ACETONIDE PADAGIS ISRAEL Labeling Approval
10/01/2025 FLUOCINOLONE ACETONIDE
ANDA #202849		 SUPPL-4 FLUOCINOLONE ACETONIDE PADAGIS ISRAEL Labeling Approval
10/01/2025 IRBESARTAN
ANDA #203534		 SUPPL-19 IRBESARTAN JUBILANT GENERICS Labeling Approval
10/01/2025 MEROPENEM
ANDA #204139		 SUPPL-3 MEROPENEM ACS DOBFAR SPA Labeling Approval
10/01/2025 MEROPENEM
ANDA #204139		 SUPPL-4 MEROPENEM ACS DOBFAR SPA Labeling Approval
10/01/2025 HYDROMORPHONE HYDROCHLORIDE
ANDA #204278		 SUPPL-22 HYDROMORPHONE HYDROCHLORIDE PADAGIS US Labeling Approval
10/01/2025 DORZOLAMIDE HYDROCHLORIDE
ANDA #204778		 SUPPL-5 DORZOLAMIDE HYDROCHLORIDE MICRO LABS Labeling Approval
10/01/2025 DORZOLAMIDE HYDROCHLORIDE
ANDA #204778		 SUPPL-10 DORZOLAMIDE HYDROCHLORIDE MICRO LABS Labeling Approval
10/01/2025 VONJO
NDA #208712		 SUPPL-4 PACRITINIB CITRATE SOBI Labeling Approval
10/01/2025 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #210369		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE GLENMARK PHARMS LTD Labeling Approval
10/01/2025 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #210369		 SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE GLENMARK PHARMS LTD Labeling Approval
10/01/2025 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #210369		 SUPPL-7 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE GLENMARK PHARMS LTD Labeling Approval
10/01/2025 PREGABALIN
ANDA #213423		 SUPPL-3 PREGABALIN CREEKWOOD PHARMS Labeling Approval
10/01/2025 PREGABALIN
ANDA #213423		 SUPPL-6 PREGABALIN CREEKWOOD PHARMS Labeling Approval
10/01/2025 PREGABALIN
ANDA #213423		 SUPPL-7 PREGABALIN CREEKWOOD PHARMS Labeling Approval
10/01/2025 CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA #215255		 ORIG-1 METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN MACLEODS PHARMACEUTICALS LTD Tentative Approval
10/01/2025 ACETAMINOPHEN AND IBUPROFEN
ANDA #216592		 SUPPL-6 ACETAMINOPHEN; IBUPROFEN GRANULES Labeling Approval
10/01/2025 BUPROPION HYDROCHLORIDE
ANDA #217898		 ORIG-1 BUPROPION HYDROCHLORIDE ANNORA PHARMA Approval
10/01/2025 MIUDELLA
NDA #218201		 SUPPL-2 COPPER SEBELA WOMENS HLTH REMS Approval
10/01/2025 PREDNISONE
ANDA #219477		 ORIG-1 PREDNISONE DR REDDYS Approval
10/01/2025 DOXYCYCLINE
ANDA #219978		 ORIG-1 DOXYCYCLINE CHANGZHOU PHARM Approval
10/02/2025 METADATE ER
ANDA #040306		 SUPPL-22 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
10/02/2025 ZEPZELCA
NDA #213702		 SUPPL-11 LURBINECTEDIN JAZZ Efficacy Approval
10/02/2025 SCEMBLIX
NDA #215358		 SUPPL-10 ASCIMINIB HYDROCHLORIDE NOVARTIS Efficacy Approval
10/02/2025 PILOCARPINE HYDROCHLORIDE
ANDA #217052		 ORIG-1 PILOCARPINE HYDROCHLORIDE FDC LTD Approval
10/02/2025 MIRTAZAPINE
ANDA #219721		 ORIG-1 MIRTAZAPINE ANNORA PHARMA Approval
10/02/2025 TECENTRIQ
BLA #761034		 SUPPL-58 ATEZOLIZUMAB GENENTECH INC Approval
10/02/2025 TECVAYLI
BLA #761291		 SUPPL-15 TECLISTAMAB-CQYV JANSSEN BIOTECH Approval
10/02/2025 TALVEY
BLA #761342		 SUPPL-16 TALQUETAMAB-TGVS JANSSEN BIOTECH Approval
10/02/2025 TECENTRIQ HYBREZA
BLA #761347		 SUPPL-3 ATEZOLIZUMAB AND HYALURONIDASE-TQJS GENENTECH INC Approval
10/02/2025 EYDENZELT
BLA #761377		 ORIG-1 AFLIBERCEPT-BOAV CELLTRION INC Approval
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