Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075412
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE 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
09/08/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-412_Timolol%20Maleate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75412ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-412_Timolol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/17/2015 SUPPL-21 Labeling

Label is not available on this site.

02/10/2007 SUPPL-16 Labeling

Label is not available on this site.

01/14/2004 SUPPL-9 Labeling

Label is not available on this site.

12/23/2002 SUPPL-4 Labeling

Label is not available on this site.

03/15/2002 SUPPL-3 Labeling

Label is not available on this site.

07/30/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/06/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/08/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-412_Timolol%20Maleate_prntlbl.pdf

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