FDA Orange BookSynced 2 d ago
FDA Orange Book: search approved drugs, generics, patents, and exclusivity
See which generics reference every brand, read therapeutic-equivalence codes at a glance, and watch patent and exclusivity cliffs approach — directly from official FDA Orange Book records.
27,198
Approved drug products
across 48,381 product strengths
5,503
Brand (NDA)
21,695
Generics (ANDA)
21,807
Listed patents
Recently approved FDA drug products
The most recently approved brand and generic drug products in the FDA Orange Book, sourced from official FDA records with therapeutic-equivalence, reference-listed-drug, patent, and exclusivity context.
Showing 48 FDA-approved drug products, including 3 brand (NDA) products and 45 generic (ANDA) products.
| Product | Ingredient | Applicant | Type | Application | TE code | Approved | Patent expiry | Copy |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | SAPTALIS PHARMS | ANDA | 220271 | AA | — | ||
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | NEPHRON | ANDA | 216272 | AP | — | ||
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | PAI HOLDINGS | ANDA | 219165 | AA | — | ||
| CEPHALEXIN | CEPHALEXIN· 2 strengths | AUROBINDO PHARMA | ANDA | 213568 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | YAOPHARMA CO LTD | ANDA | 215552 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | CONCORD BIOTECH LTD | ANDA | 218821 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | SAPTALIS PHARMS | ANDA | 218900 | AA | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | AUSON | ANDA | 219370 | AA | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | ORIENT PHARMA | ANDA | 219830 | AB | — | ||
| GADOBUTROL | GADOBUTROL· 6 strengths | ZENARA | ANDA | 219146 | AP | — | ||
| GALLIUM GA 68 GOZETOTIDE | GALLIUM GA-68 GOZETOTIDE | RADIOMEDIX | ANDA | 216410 | AP | — | ||
| MACITENTAN | MACITENTAN | AMNEAL | ANDA | 211000 | AB | — | ||
| MACITENTAN | MACITENTAN | TEVA PHARMS USA INC | ANDA | 211187 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | ZYDUS PHARMS | ANDA | 209829 | AB | — | ||
| CANGRELOR | CANGRELOR | MSN | ANDA | 213703 | AP | — | ||
| DALBAVANCIN HYDROCHLORIDE | DALBAVANCIN HYDROCHLORIDE | BE PHARMS | ANDA | 219604 | AP | — | ||
| HALOPERIDOL | HALOPERIDOL· 5 strengths | ALEMBIC | ANDA | 214470 | AB | — | ||
| RAMELTEON | RAMELTEON | HIBROW HLTHCARE | ANDA | 215485 | AB | — | ||
| DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | SUN PHARM | ANDA | 204196 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | BRECKENRIDGE | ANDA | 209633 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | MICRO LABS | ANDA | 209738 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | AUROBINDO PHARMA LTD | ANDA | 215356 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | MSN | ANDA | 217298 | AA | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | MSN | ANDA | 217299 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | APOTEX | ANDA | 218096 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | SUN PHARM INDS INC | ANDA | 218407 | AA | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | SPECGX LLC | ANDA | 219395 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | MACLEODS PHARMS LTD | ANDA | 219530 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE· 2 strengths | SOMERSET THERAPS LLC | ANDA | 220137 | AB | — | ||
| TOFACITINIB CITRATE | TOFACITINIB CITRATE | APOTEX | ANDA | 220458 | AB | — | ||
| VASOPRESSIN IN DEXTROSE 5% | VASOPRESSIN· 2 strengths | DR REDDYS | ANDA | 213988 | AP | — | ||
| ELUXADOLINE | ELUXADOLINE· 2 strengths | AUROBINDO PHARMA | ANDA | 213511 | AB | — | ||
| ROMIDEPSIN | ROMIDEPSIN | AMNEAL | ANDA | 219099 | — | — | ||
| CYCLOSPORINE | CYCLOSPORINE | JIANGSU ANBISON | ANDA | 219288 | AB | — | ||
| ERIBULIN MESYLATE | ERIBULIN MESYLATE | NATCO | ANDA | 217085 | AP | — | ||
| FLUORESCEIN SODIUM | FLUORESCEIN SODIUM· 2 strengths | ZYDUS LIFESCIENCES | ANDA | 218651 | AP | — | ||
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | CONCORD BIOTECH LTD | ANDA | 218566 | AB | — | ||
| PHYTONADIONE | PHYTONADIONE | AMNEAL | ANDA | 217734 | AB1 | — | ||
| ZAYNICH | CEFEPIME HYDROCHLORIDE; ZIDEBACTAM | WOCKHARDT BIO AG | NDA | 220787 | — | — | ||
| XOCOVA | ENSITRELVIR | SHIONOGI | NDA | 220442 | — | — | ||
| EPINEPHRINE | EPINEPHRINE | HIKMA | ANDA | 220562 | AP | — | ||
| CAVHANZA | NILOTINIB· 2 strengths | FLEX PHARMA | NDA | 217379 | — | — | ||
| OXCARBAZEPINE | OXCARBAZEPINE | MSN | ANDA | 209020 | AB | — | ||
| DEFLAZACORT | DEFLAZACORT | CARNEGIE | ANDA | 220709 | AB | — | ||
| SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE | LUPIN | ANDA | 216095 | AB | — | ||
| CARBOPROST TROMETHAMINE | CARBOPROST TROMETHAMINE | SOMERSET THERAPS LLC | ANDA | 219529 | AP | — | ||
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM· 3 strengths | HETERO LABS LTD V | ANDA | 219869 | AB | — | ||
| LINAGLIPTIN | LINAGLIPTIN | TEVA PHARMS USA | ANDA | 208433 | AB | — |
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