FDA NDA · NDA011265

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Sponsor: ANI PHARMS

APPLICATION

NDA011265

TYPE

NDA

ORIGINAL APPROVAL

1957-12-03

LATEST ACTION

2009-09-16

ROUTE

ORAL

DOSAGE FORM

SYRUP

MARKETING STATUS

Prescription

Products

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE · ReferencePrescription

DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL

2009-09-16Labeling · Supplement 31 · standard — Letter ↗AP

2008-04-02Manufacturing (CMC) · Supplement 29 — Letter ↗AP

2004-01-16Labeling · Supplement 28 · standard — Letter ↗AP

2001-02-23Labeling · Supplement 27 · standard — Review ↗AP

1998-05-06Manufacturing (CMC) · Supplement 25 · standardAP

1996-02-27Labeling · Supplement 24 · standardAP

1992-03-30Manufacturing (CMC) · Supplement 23 · standardAP

1989-11-16Manufacturing (CMC) · Supplement 22 · standardAP

1988-08-11Efficacy · Supplement 19AP

1988-06-30Manufacturing (CMC) · Supplement 21 · standardAP

1986-05-29Manufacturing (CMC) · Supplement 15 · standardAP

1985-09-16Labeling · Supplement 18AP

1985-07-31Manufacturing (CMC) · Supplement 16 · standardAP

1984-04-11Labeling · Supplement 14AP

1984-04-02Manufacturing (CMC) · Supplement 12 · standardAP

1984-04-02Efficacy · Supplement 13AP

1957-12-03Type 4 - New Combination · Original · standardAP

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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