Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080615
Company: WATSON LABS TEVA

Products on ANDA 080615

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIMENHYDRINATE	DIMENHYDRINATE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080615

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1974	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
02/19/1999	SUPPL-171	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
11/02/1998	SUPPL-170	Manufacturing (CMC)		Label is not available on this site.
02/02/1999	SUPPL-169	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/27/1996	SUPPL-168	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/11/1991	SUPPL-167	Labeling		Label is not available on this site.
09/27/1989	SUPPL-166	Manufacturing (CMC)		Label is not available on this site.
09/27/1989	SUPPL-165	Manufacturing (CMC)		Label is not available on this site.
03/31/1989	SUPPL-164	Manufacturing (CMC)		Label is not available on this site.
08/03/1988	SUPPL-162	Manufacturing (CMC)		Label is not available on this site.
08/03/1988	SUPPL-161	Manufacturing (CMC)		Label is not available on this site.
09/19/1988	SUPPL-159	Manufacturing (CMC)		Label is not available on this site.
05/28/1986	SUPPL-157	Manufacturing (CMC)		Label is not available on this site.
04/05/1982	SUPPL-154	Manufacturing (CMC)		Label is not available on this site.