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FDA Orange Book · active-ingredient family

Pentobarbital sodium

Pentobarbital sodium is approved in 27 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

27

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (27)

ProductApplicantApplicationTEApproved
PENTOBARBITAL SODIUMBPI LABSANDA 206677APNov 27, 2017
PENTOBARBITAL SODIUMHIKMAANDA 203619APNov 13, 2017
PENTOBARBITAL SODIUMSAGENT PHARMS INCANDA 206404APMay 23, 2016
NEMBUTAL×4SCIEGEN PHARMSANDA 083247—Jan 25, 1982
NEMBUTAL SODIUMEPIC PHARMA LLCANDA 084095—Approved Prior to Jan 1, 1982
NEMBUTAL SODIUMEPIC PHARMA LLCANDA 084093—Approved Prior to Jan 1, 1982
NEMBUTAL SODIUMEPIC PHARMA LLCANDA 083245—Approved Prior to Jan 1, 1982
PENTOBARBITAL SODIUMLANNETTANDA 085937—Approved Prior to Jan 1, 1982
PENTOBARBITAL SODIUMLANNETTANDA 085915—Approved Prior to Jan 1, 1982
PENTOBARBITAL SODIUMVITARINEANDA 083284—Approved Prior to Jan 1, 1982
PENTOBARBITAL SODIUMWHITEWORTH TOWN PLSNANDA 083338—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALANABOLICANDA 084590—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALELKINS SINNANDA 083368—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALEVERYLIFEANDA 083259—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALHALSEYANDA 084677—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITAL×2IVAX SUB TEVA PHARMSANDA 083461—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALPARKE DAVISANDA 084156—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALPERRIGOANDA 084560—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALPUREPAC PHARMANDA 083301—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALVALEANT PHARM INTLANDA 083264—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALWATSON LABSANDA 085791—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALWYETH AYERSTANDA 083239—Approved Prior to Jan 1, 1982
NEMBUTAL SODIUMRLDRISINGANDA 083246APApproved Prior to Jan 1, 1982
PENTOBARBITAL SODIUMELKINS SINNANDA 083270—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALWYETH AYERSTANDA 083261—Approved Prior to Jan 1, 1982
PENTOBARBITAL SODIUMVITARINEANDA 083285—Approved Prior to Jan 1, 1982
SODIUM PENTOBARBITALNEXGEN PHARMA INCANDA 084238—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.

Pentobarbital sodium — frequently asked questions

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

Agent CTA Background

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