Assyro AI

FDA Orange Book · active-ingredient family

Heparin sodium

Heparin sodium is approved as 32 brand and 54 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HEPARIN SODIUM · NDA 201370

32

Brand (NDA)

54

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
HEPARIN SODIUMRLD×4PFIZERNDA 201370—Jul 21, 2011
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×4B BRAUNNDA 019953APJul 20, 1992
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×3B BRAUNNDA 019952—Jul 20, 1992
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD×11HOSPIRANDA 018916APJun 23, 1989
HEPARIN SODIUMRLD×16FRESENIUS KABI USANDA 017029APApproved Prior to Jan 1, 1982
HEPARIN SODIUMRLD×4FRESENIUS KABI USANDA 017651APApproved Prior to Jan 1, 1982
HEPARIN SODIUMRLD×8HIKMANDA 017007—Approved Prior to Jan 1, 1982
HEPARIN SODIUMRLD×4HIKMANDA 017037APApproved Prior to Jan 1, 1982
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER×4B BRAUNNDA 019802—Jul 20, 1992
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER×2HOSPIRANDA 019805—Jan 25, 1989
SODIUM HEPARINBAXTER HLTHCARENDA 017036—Mar 04, 1988
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER×4BAXTER HLTHCARENDA 018814—Jul 09, 1985
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×3B BRAUNNDA 019042—Mar 29, 1985
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERB BRAUNNDA 019134—Mar 29, 1985
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERB BRAUNNDA 019135—Mar 29, 1985
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER×4HOSPIRANDA 019339APMar 27, 1985
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%×9HOSPIRANDA 018911—Jan 30, 1985
HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER×3MCGAWNDA 019130—Dec 31, 1984
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×3BAXTER HLTHCARENDA 018609APApr 28, 1982
HEPARIN LOCK FLUSH×8HOSPIRANDA 005264—Approved Prior to Jan 1, 1982
HEPARIN LOCK FLUSH×6PARKE DAVISNDA 017346—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×4ABRAXIS PHARMNDA 017033—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×3ABRAXIS PHARMNDA 017979—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×12ASPEN GLOBAL INCNDA 000552—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×4CHAMBERLIN PARENTERLNDA 017130—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×5DELL LABSNDA 017540—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×10DR REDDYSNDA 017064—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×5EPIC PHARMA LLCNDA 017486—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×3LILLYNDA 005521—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×5PHARM SPECNDA 017780—Approved Prior to Jan 1, 1982
HEPARIN SODIUM×3PHARMACIA AND UPJOHNNDA 004570—Approved Prior to Jan 1, 1982
LIPO-HEPIN×113MNDA 017027—Approved Prior to Jan 1, 1982

Generic (ANDA) products (54)

ProductApplicantApplicationTEApproved
HEPARIN SODIUMBE PHARMSANDA 214804APDec 29, 2020
HEPARIN SODIUMBE PHARMSANDA 214839APDec 29, 2020
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2FRESENIUS KABI USAANDA 212441APJul 24, 2020
HEPARIN SODIUMEMERGE BIOSCIENCEANDA 212061APJul 15, 2020
HEPARIN SODIUM PRESERVATIVE FREEEMERGE BIOSCIENCEANDA 212060APApr 02, 2020
HEPARIN SODIUMEMERGE BIOSCIENCEANDA 211004APFeb 24, 2020
HEPARIN SODIUM×2GLANDANDA 205323APNov 18, 2019
HEPARIN SODIUM×3EMERGE BIOSCIENCEANDA 211007APMay 28, 2019
HEPARIN SODIUMEMERGE BIOSCIENCEANDA 211005APDec 14, 2018
HEPARIN SODIUMB BRAUN MEDICALANDA 208827—Nov 19, 2018
HEPARIN SODIUM×3PHARMOBEDIENTANDA 203851APNov 30, 2017
HEPARIN SODIUMPHARMOBEDIENTANDA 203852—Nov 30, 2017
HEPARIN SODIUMFRESENIUS KABI USAANDA 206552APJun 10, 2016
HEPARIN SODIUM×2SHENZHEN TECHDOWANDA 202957APJun 12, 2014
HEPARIN SODIUMSHENZHEN TECHDOWANDA 202733APJun 12, 2014
HEPARIN SODIUM×2SHENZHEN TECHDOWANDA 203198APJun 12, 2014
HEPARIN SODIUM PRESERVATIVE FREESHENZHEN TECHDOWANDA 202732APJun 12, 2014
HEPARIN SODIUMCASI PHARMS INCANDA 091659—Jun 08, 2011
HEPARIN SODIUM×2PLANO PHARMSANDA 091682APJun 08, 2011
HEPARIN SODIUMPLANO PHARMSANDA 201002APJun 08, 2011
HEPARIN SODIUM×3SAGENT PHARMSANDA 090808APJun 30, 2010
HEPARIN SODIUMSAGENT PHARMSANDA 090809APJun 30, 2010
HEPARIN SODIUM PRESERVATIVE FREESAGENT PHARMSANDA 090810APJun 30, 2010
HEPARIN SODIUM×3HOSPIRA INCANDA 090571APAug 31, 2009
HEPARIN SODIUMHOSPIRAANDA 040095—Jul 26, 1996
HEPARIN SODIUMDR REDDYSANDA 040007—Jun 07, 1996
HEPARIN SODIUMWATSON LABS INCANDA 040008—Oct 10, 1995
HEPARIN SODIUM PRESERVATIVE FREEHOSPIRAANDA 089522APMay 04, 1987
HEPARIN SODIUM PRESERVATIVE FREEDR REDDYSANDA 089464—Jun 03, 1986
HEPARIN LOCK FLUSHLUITPOLDANDA 089063—Oct 09, 1985
HEPARIN LOCK FLUSHLUITPOLDANDA 089064—Oct 09, 1985
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 088580—Oct 25, 1984
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 088581—Oct 25, 1984
HEPARIN LOCK FLUSHSOLOPAKANDA 088457—Oct 25, 1984
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 088458—Jul 26, 1984
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 088460—Jul 26, 1984
HEPARIN LOCK FLUSHSOLOPAKANDA 088459—Jul 26, 1984
HEPARIN SODIUMSMITH AND NEPHEWANDA 088239—Jul 26, 1984
HEPARIN SODIUMLUITPOLDANDA 087452—Oct 31, 1983
HEPARIN SODIUMHOSPIRAANDA 088099—Apr 28, 1983
HEPARIN SODIUMHOSPIRAANDA 088100—Apr 28, 1983
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 087904—Apr 20, 1983
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 087958—Apr 20, 1983
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 087906—Apr 20, 1983
HEPARIN LOCK FLUSHSMITH AND NEPHEWANDA 087959—Apr 20, 1983
HEPARIN LOCK FLUSHSOLOPAKANDA 087903—Apr 20, 1983
HEPARIN LOCK FLUSHSOLOPAKANDA 087905—Apr 20, 1983
HEPARIN LOCK FLUSH×2INTL MEDICATIONANDA 086357—Approved Prior to Jan 1, 1982
HEPARIN SODIUMSOLOPAKANDA 087043—Approved Prior to Jan 1, 1982
HEPARIN SODIUMSOLOPAKANDA 087077—Approved Prior to Jan 1, 1982
HEPARIN SODIUMSOLOPAKANDA 087395—Approved Prior to Jan 1, 1982
HEPARIN SODIUMSOLOPAKANDA 087107—Approved Prior to Jan 1, 1982
HEPARIN SODIUMSOLOPAKANDA 087363—Approved Prior to Jan 1, 1982
HEPARIN SODIUM PRESERVATIVE FREEPHARMA SERVE NYANDA 086129—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Heparin sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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