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FDA ANDA · ANDA083246

NEMBUTAL SODIUM

Sponsor: RISING

APPLICATION
ANDA083246
TYPE
ANDA
ORIGINAL APPROVAL
1973-09-19
LATEST ACTION
2017-04-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NEMBUTAL SODIUM · ReferencePrescription
PENTOBARBITAL SODIUM 50MG/ML · INJECTABLE · INJECTION

Approval history

2017-04-27Labeling · Supplement 37 · standardAP
2007-05-12Labeling · Supplement 25AP
2003-09-25Labeling · Supplement 23AP
2002-05-10Manufacturing (CMC) · Supplement 22AP
2002-05-10Manufacturing (CMC) · Supplement 21AP
1992-12-29Manufacturing (CMC) · Supplement 19AP
1986-04-09Manufacturing (CMC) · Supplement 18AP
1985-06-17Manufacturing (CMC) · Supplement 17AP
1973-09-19OriginalAP
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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