Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008604
Company: ANI PHARMS

Products on NDA 008604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENERGAN VC	PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SYRUP;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/1954	ORIG-1	Approval	Type 4 - New Combination	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
02/23/2001	SUPPL-26	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008604_S026_PHENERGRAN_VC_AP.pdf
05/06/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/30/1992	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
11/16/1989	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
08/11/1988	SUPPL-16	Efficacy-Rx To OTC Switch		Label is not available on this site.
09/14/1985	SUPPL-15	Labeling		Label is not available on this site.
07/30/1985	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
05/29/1986	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/1984	SUPPL-12	Labeling		Label is not available on this site.
04/02/1984	SUPPL-11	Efficacy		Label is not available on this site.
04/02/1984	SUPPL-10	Manufacturing (CMC)-Formulation		Label is not available on this site.