Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062523
Company: ALCON PHARMS LTD

Products on ANDA 062523

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062523

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/1985	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
06/16/1999	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
02/19/1999	SUPPL-19	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-16	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/1996	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/16/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/27/1995	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/18/1994	SUPPL-12	Labeling		Label is not available on this site.
01/27/1994	SUPPL-11	Labeling		Label is not available on this site.
10/16/1991	SUPPL-10	Labeling		Label is not available on this site.
11/22/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/11/1992	SUPPL-8	Labeling		Label is not available on this site.
02/11/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/29/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.