Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062721
Company: ALCON PHARMS LTD

Products on ANDA 062721

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062721

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/1986	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-15	Manufacturing (CMC)		Label is not available on this site.
02/19/1999	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/07/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/02/1999	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/07/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/25/1998	SUPPL-9	Labeling		Label is not available on this site.
04/16/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/27/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-6	Labeling		Label is not available on this site.
10/14/1993	SUPPL-5	Labeling		Label is not available on this site.
10/31/1991	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/12/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.