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FDA ANDA · ANDA040737

PROMETHAZINE HYDROCHLORIDE

Sponsor: XGEN PHARMS

APPLICATION
ANDA040737
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-24
LATEST ACTION
2023-12-27
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION

Approval history

2023-12-27Labeling · Supplement 8 · standardAP
2009-11-19Labeling · Supplement 1AP
2008-04-24Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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