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FDA ANDA · ANDA040785

PROMETHAZINE HYDROCHLORIDE

Sponsor: WOCKHARDT BIO AG

APPLICATION
ANDA040785
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-26
LATEST ACTION
2015-02-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2015-02-13Labeling · Supplement 1AP
2009-12-11Labeling · Supplement 2AP
2008-09-26Original — 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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