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FDA NDA · NDA012427

DIDREX

Sponsor: PFIZER

APPLICATION
NDA012427
TYPE
NDA
ORIGINAL APPROVAL
1960-10-26
LATEST ACTION
2020-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DIDREX · ReferenceDiscontinued
BENZPHETAMINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DIDREX · ReferenceDiscontinued
BENZPHETAMINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2020-04-08Labeling · Supplement 31 · standard — Letter ↗AP
2010-02-05Labeling · Supplement 26 · unknown — Letter ↗AP
2000-07-28Labeling · Supplement 21AP
2000-07-27Labeling · Supplement 20AP
1998-09-23Manufacturing (CMC) · Supplement 23 · standardAP
1992-07-31Manufacturing (CMC) · Supplement 22 · standardAP
1985-12-31Labeling · Supplement 19AP
1984-09-04Labeling · Supplement 18AP
1960-10-26Type 1 - New Molecular Entity · Original · standardAP
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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