Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080021
Company: ALCON

Products on ANDA 080021

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CETAMIDE	SULFACETAMIDE SODIUM	10%	OINTMENT;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080021

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1972	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
01/18/2000	SUPPL-17	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/23/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/12/1996	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/18/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/18/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/23/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-11	Labeling		Label is not available on this site.
08/19/1992	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-9	Labeling		Label is not available on this site.
07/05/1991	SUPPL-8	Labeling		Label is not available on this site.
03/09/1990	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/15/1989	SUPPL-6	Labeling		Label is not available on this site.
03/09/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/30/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.