Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 081044
Company: ALCON PHARMS LTD

Products on ANDA 081044

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 081044

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/1991	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
06/11/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/19/1999	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/1996	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/31/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/16/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/02/1993	SUPPL-2	Labeling		Label is not available on this site.
06/10/1994	SUPPL-1	Labeling		Label is not available on this site.