Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084394
Company: ACTAVIS MID ATLANTIC

Products on ANDA 084394

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SELENIUM SULFIDE	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084394

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/1975	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
12/06/2001	SUPPL-61	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/2001	SUPPL-60	Manufacturing (CMC)		Label is not available on this site.
01/25/1991	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
09/28/1990	SUPPL-56	Manufacturing (CMC)		Label is not available on this site.
01/25/1991	SUPPL-55	Manufacturing (CMC)		Label is not available on this site.
07/18/1990	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
02/08/1989	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
02/08/1989	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
12/19/1989	SUPPL-50	Labeling		Label is not available on this site.
12/14/1984	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
01/18/1983	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
01/18/1983	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
01/18/1983	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
02/17/1983	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.