Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083246
Company: OAK PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEMBUTAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/19/1973 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2017 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

05/12/2007 SUPPL-25 Labeling

Label is not available on this site.

09/25/2003 SUPPL-23 Labeling

Label is not available on this site.

05/10/2002 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

05/10/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

12/29/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/09/1986 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/17/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

NEMBUTAL SODIUM

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEMBUTAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 083246 OAK PHARMS
PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 206677 ATHENEX
PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 203619 CUSTOPHARM INC
PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 206404 SAGENT PHARMS INC

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