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FDA ANDA · ANDA086101

SECONAL SODIUM

Sponsor: VALEANT PHARMS NORTH

APPLICATION
ANDA086101
TYPE
ANDA
ORIGINAL APPROVAL
1983-10-03
LATEST ACTION
2018-06-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SECONAL SODIUMDiscontinued
SECOBARBITAL SODIUM 50MG · CAPSULE · ORAL
SECONAL SODIUMDiscontinued
SECOBARBITAL SODIUM 100MG · CAPSULE · ORAL

Approval history

2018-06-08Labeling · Supplement 23 · standardAP
2008-08-20Labeling · Supplement 21AP
2007-06-27Labeling · Supplement 20AP
2003-09-25Labeling · Supplement 17AP
2003-08-20Labeling · Supplement 15AP
1998-09-09Manufacturing (CMC) · Supplement 11AP
1998-03-17Manufacturing (CMC) · Supplement 10AP
1995-07-07Manufacturing (CMC) · Supplement 9AP
1991-03-28Labeling · Supplement 8AP
1990-10-03Labeling · Supplement 6AP
1989-08-02Labeling · Supplement 5AP
1988-09-09Manufacturing (CMC) · Supplement 4AP
1988-08-24Bioequivalence · Supplement 1AP
1986-07-03Manufacturing (CMC) · Supplement 2AP
1986-07-03Manufacturing (CMC) · Supplement 3AP
1983-10-03Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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