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FDA ANDA · ANDA071309

DIAZEPAM

Sponsor: HIKMA

APPLICATION
ANDA071309
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-17
LATEST ACTION
2023-01-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DIAZEPAMDiscontinued
DIAZEPAM 5MG/ML · INJECTABLE · INJECTION

Approval history

2023-01-17Labeling · Supplement 9 · standardAP
2022-03-23Labeling · Supplement 8 · standard — Label ↗AP
2021-02-05Labeling · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-08Labeling · Supplement 5 · standardAP
1994-08-25Labeling · Supplement 4AP
1993-06-16Manufacturing (CMC) · Supplement 3AP
1991-01-18Labeling · Supplement 2AP
1988-01-05Manufacturing (CMC) · Supplement 1AP
1987-07-17OriginalAP
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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