Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040065
Company: BAUSCH AND LOMB

Products on ANDA 040065

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040065

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1994	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
11/27/2001	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/07/2001	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/05/2000	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/28/2000	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/18/2000	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/07/1999	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.