Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050537
Company: PFIZER

Products on NDA 50537

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLEOCIN	CLINDAMYCIN PHOSPHATE	EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SWAB;TOPICAL	Discontinued	None	Yes	No
CLEOCIN T	CLINDAMYCIN PHOSPHATE	EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 050537

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2025	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050537s042,050600s020,050615s021lbl.pdf
12/16/2019	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s041,050600s018,050615s019lbl.pdf
04/19/2019	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf
11/16/2017	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf
01/15/2016	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf
04/04/2014	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf
05/30/2003	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf
07/14/2002	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf