Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086101
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SECONAL SODIUM SECOBARBITAL SODIUM 50MG CAPSULE;ORAL Prescription None No Yes
SECONAL SODIUM SECOBARBITAL SODIUM 100MG CAPSULE;ORAL Prescription None 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
10/03/1983 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
06/08/2018 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/20/2008 SUPPL-21 Labeling

Label is not available on this site.

06/27/2007 SUPPL-20 Labeling

Label is not available on this site.

09/25/2003 SUPPL-17 Labeling

Label is not available on this site.

08/20/2003 SUPPL-15 Labeling

Label is not available on this site.

09/09/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/07/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/28/1991 SUPPL-8 Labeling

Label is not available on this site.

10/03/1990 SUPPL-6 Labeling

Label is not available on this site.

08/02/1989 SUPPL-5 Labeling

Label is not available on this site.

09/09/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/03/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/03/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/24/1988 SUPPL-1 Bioequivalence

Label is not available on this site.

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