Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010926
Company: PHARMOBEDIENT

Products on NDA 10926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No

Labels for NDA 010926

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2004	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf