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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012427
Company: PFIZER

Products on NDA 012427

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIDREX	BENZPHETAMINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
DIDREX	BENZPHETAMINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012427

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/1960	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2020	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012427s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012427Orig1s031ltr.pdf
02/05/2010	SUPPL-26	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012427s026ltr.pdf
09/23/1998	SUPPL-23	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/31/1992	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/2000	SUPPL-21	Labeling		Label is not available on this site.
07/27/2000	SUPPL-20	Labeling		Label is not available on this site.
12/31/1985	SUPPL-19	Labeling		Label is not available on this site.
09/04/1984	SUPPL-18	Labeling		Label is not available on this site.

Labels for NDA 012427

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2020	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012427s031lbl.pdf
02/05/2010	SUPPL-26	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf

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