Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075411
Company: APOTEX INC

Products on ANDA 075411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075411

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/2000/75411_Timolol%20Maleate%20Ophthalmic_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75411ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075411_timolol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
04/03/2020	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
01/21/2015	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.

Labels for ANDA 075411

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/2000/75411_Timolol%20Maleate%20Ophthalmic_Prntlbl.pdf