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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050567
Company: ALLERGAN

Products on NDA 050567

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POLYTRIM	POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050567

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/1988	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2025	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050567s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050567Orig1s028ltr.pdf
03/19/2003	SUPPL-22	Labeling		Label is not available on this site.
04/12/2002	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/2001	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/12/2001	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/18/2000	SUPPL-16	Labeling		Label is not available on this site.
12/05/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/02/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/04/1998	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
12/02/1998	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/19/1998	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/23/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
12/31/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/03/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/03/1995	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/02/1996	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/1993	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/08/1992	SUPPL-3	Labeling		Label is not available on this site.
07/02/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050567

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2025	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050567s028lbl.pdf

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