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FDA ANDA · ANDA211998

DIAZEPAM

Sponsor: REGCON HOLDINGS

APPLICATION
ANDA211998
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-26
LATEST ACTION
2024-11-12
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DIAZEPAMPrescription
DIAZEPAM 50MG/10ML (5MG/ML) · INJECTABLE · INJECTION

Approval history

2024-11-12Labeling · Supplement 9 · standardAP
2023-02-08Labeling · Supplement 7 · standardAP
2021-08-10Labeling · Supplement 6 · standard — Label ↗AP
2021-05-21Labeling · Supplement 4 · standardAP
2021-05-21Labeling · Supplement 3 · standardAP
2021-02-08Labeling · Supplement 2 · standardAP
2019-12-26UNKNOWN · Original · standard — Letter ↗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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