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FDA NDA · NDA011689

PHENERGAN

Sponsor: PHARMOBEDIENT

APPLICATION
NDA011689
TYPE
NDA
ORIGINAL APPROVAL
1960-04-27
LATEST ACTION
2015-08-04
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued

Products

PHENERGAN · ReferenceDiscontinued
PROMETHAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL

Approval history

2015-08-04Manufacturing (CMC) · Supplement 25 · standardAP
2004-11-08Labeling · Supplement 24 · standard — Label ↗AP
2002-12-26Labeling · Supplement 18 · standard — Letter ↗AP
2002-12-26Labeling · Supplement 16 · standard — Letter ↗AP
2002-12-26Labeling · Supplement 20 · standard — Letter ↗AP
2002-12-26Labeling · Supplement 19 · standard — Letter ↗AP
2001-09-12Manufacturing (CMC) · Supplement 21 · standardAP
2001-08-01Manufacturing (CMC) · Supplement 17 · standardAP
1994-07-01Manufacturing (CMC) · Supplement 15 · standardAP
1993-04-28Manufacturing (CMC) · Supplement 13 · standardAP
1992-03-30Manufacturing (CMC) · Supplement 14 · standardAP
1988-06-30Manufacturing (CMC) · Supplement 10 · standardAP
1988-01-22Labeling · Supplement 9AP
1986-05-29Manufacturing (CMC) · Supplement 6 · standardAP
1960-04-27Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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