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FDA Orange Book · active-ingredient family

Ampicillin sodium; sulbactam sodium

Ampicillin sodium; sulbactam sodium is approved as 1 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:UNASYN · NDA 050608

1

Brand (NDA)

24

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
UNASYNRLD×4PFIZERNDA 050608APDec 31, 1986

Generic (ANDA) products (24)

ProductApplicantApplicationTEApproved
AMPICILLIN AND SULBACTAMASTRALANDA 090578—Jan 11, 2016
AMPICILLIN AND SULBACTAM×2ASTRALANDA 090579—Jan 08, 2016
AMPICILLIN AND SULBACTAM×2ANTIBIOTICEANDA 201406APDec 07, 2015
AMPICILLIN AND SULBACTAM×2ONESOURCE SPECIALTYANDA 201024APApr 07, 2014
AMPICILLIN AND SULBACTAMONESOURCE SPECIALTYANDA 202197APApr 07, 2014
AMPICILLIN AND SULBACTAM×2HOSPIRA INCANDA 090375—Dec 21, 2011
AMPICILLIN AND SULBACTAM×2HOSPIRA INCANDA 090653—Dec 21, 2011
AMPICILLIN AND SULBACTAMHOSPIRA INCANDA 090646—Dec 21, 2011
AMPICILLIN AND SULBACTAM×2EUGIA PHARMA SPECLTSANDA 090340—Sep 20, 2010
AMPICILLIN AND SULBACTAM×2EUGIA PHARMA SPECLTSANDA 090349APSep 20, 2010
AMPICILLIN AND SULBACTAMEUGIA PHARMA SPECLTSANDA 090339APSep 20, 2010
AMPICILLIN AND SULBACTAMACS DOBFARANDA 065403APDec 23, 2009
AMPICILLIN AND SULBACTAM×2ACS DOBFARANDA 065406APDec 22, 2009
AMPICILLIN AND SULBACTAM×2EUROFARMAANDA 065316—Jun 29, 2007
AMPICILLIN AND SULBACTAMISTITUTO BIO ITA SPAANDA 065314APNov 27, 2006
AMPICILLIN AND SULBACTAM×2SANDOZANDA 065241APJul 25, 2006
AMPICILLIN AND SULBACTAM×2SANDOZANDA 065310—Jul 25, 2006
AMPICILLIN AND SULBACTAMSANDOZANDA 065240APJul 25, 2006
AMPICILLIN AND SULBACTAM×2HQ SPECLT PHARMAANDA 065176APNov 30, 2005
AMPICILLIN AND SULBACTAM×2ISTITUTO BIO ITA SPAANDA 065222APNov 29, 2005
AMPICILLIN AND SULBACTAMHQ SPECLT PHARMAANDA 065188APNov 25, 2005
AMPICILLIN AND SULBACTAM×2HIKMAANDA 065074—Mar 19, 2002
AMPICILLIN AND SULBACTAMHIKMAANDA 065076APMar 19, 2002
UNASYN×2PFIZERANDA 062901—Feb 27, 1992

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.

Ampicillin sodium; sulbactam sodium — frequently asked questions

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

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