Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080738
Company: HERITAGE PHARMA

Products on ANDA 080738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080738

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/1972	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
12/21/1999	SUPPL-88	Manufacturing (CMC)-Facility		Label is not available on this site.
05/20/1999	SUPPL-85	Manufacturing (CMC)		Label is not available on this site.
05/21/1999	SUPPL-84	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-83	Manufacturing (CMC)		Label is not available on this site.
09/08/1998	SUPPL-82	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-81	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-80	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-79	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-77	Manufacturing (CMC)		Label is not available on this site.
09/13/1991	SUPPL-76	Manufacturing (CMC)		Label is not available on this site.
03/10/1988	SUPPL-75	Labeling		Label is not available on this site.
04/17/1986	SUPPL-69	Manufacturing (CMC)		Label is not available on this site.
03/28/1986	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
03/28/1986	SUPPL-67	Manufacturing (CMC)		Label is not available on this site.
03/08/1983	SUPPL-63	Manufacturing (CMC)		Label is not available on this site.