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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050615
Company: PFIZER

Products on NDA 050615

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLEOCIN T	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	AB1	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050615

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/1987	ORIG-1	Approval	Type 3 - New Dosage Form	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
12/16/2019	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s041,050600s018,050615s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050600Orig1s018,050615Orig1s019,050537Orig1s041ltr.pdf
04/19/2019	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050537Orig1s040,050600Orig1s017,050615Orig1s018ltr.pdf
11/16/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050537Orig1s039,050600Orig1s016,050615Orig1s016ltr.pdf
01/15/2016	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf
01/12/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/04/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf
05/30/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf
01/27/1998	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/14/2002	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf

Labels for NDA 050615

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s041,050600s018,050615s019lbl.pdf
04/19/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf
11/16/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf
01/15/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf
04/04/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf
05/30/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf
07/14/2002	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf

Therapeutic Equivalents for NDA 050615

CLEOCIN T

GEL;TOPICAL; EQ 1% BASE
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN T	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	Yes	AB1	050615	PFIZER
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	212466	ALEMBIC
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	212438	ENCUBE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	064160	FOUGERA PHARMS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	214251	GLENMARK PHARMS LTD
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	212104	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	211872	SOLARIS PHARMA CORP
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	214052	TARO
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB1	216587	ZYDUS LIFESCIENCES

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