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FDA ANDA · ANDA040712

PROMETHAZINE HYDROCHLORIDE

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APPLICATION
ANDA040712
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-31
LATEST ACTION
2007-05-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL

Approval history

2007-05-04Manufacturing (CMC) · Supplement 5AP
2007-05-04Manufacturing (CMC) · Supplement 3AP
2007-05-04Manufacturing (CMC) · Supplement 1AP
2007-05-04Manufacturing (CMC) · Supplement 6AP
2007-05-04Manufacturing (CMC) · Supplement 4AP
2007-05-04Labeling · Supplement 2AP
2006-07-31Original — 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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