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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075720
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METIPRANOLOL METIPRANOLOL HYDROCHLORIDE 0.3% SOLUTION/DROPS;OPHTHALMIC Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/06/2001 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
12/23/2002 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/01/2002 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2002 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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