Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087513
Company: PHARM ASSOC

Products on ANDA 087513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/10/1982	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
06/10/2009	SUPPL-12	Labeling		Label is not available on this site.
03/20/1996	SUPPL-10	Labeling		Label is not available on this site.
11/21/1990	SUPPL-9	Labeling		Label is not available on this site.
04/12/1990	SUPPL-8	Labeling		Label is not available on this site.
11/12/1991	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/14/1988	SUPPL-6	Labeling		Label is not available on this site.
07/25/1988	SUPPL-5	Labeling		Label is not available on this site.
09/09/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087513

DIPHENHYDRAMINE HYDROCHLORIDE

ELIXIR;ORAL; 12.5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	219470	ANNORA PHARMA
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR;ORAL	Prescription	Yes	AA	087513	PHARM ASSOC