Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074850
Company: SANDOZ

Products on ANDA 074850

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOBUNOLOL HYDROCHLORIDE	LEVOBUNOLOL HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074850

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/1996	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
04/08/2005	SUPPL-13	Labeling		Label is not available on this site.
12/23/2002	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/01/2002	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/29/2002	SUPPL-10	Labeling		Label is not available on this site.
03/27/2002	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/02/2002	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/07/2000	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/28/2000	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/23/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/21/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/07/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/04/1999	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/04/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.