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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050767
Company: PFIZER

Products on NDA 050767

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLEOCIN	CLINDAMYCIN PHOSPHATE	100MG	SUPPOSITORY;VAGINAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050767

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/1999	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50767lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50767ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50767_Cleocin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2022	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050767Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050767Orig1s019ltr.pdf
05/17/2022	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050767s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050767Orig1s018ltr.pdf
03/23/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050680s018,050767s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050680Orig1s018, 050767Orig1s017ltr.pdf
09/16/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050767s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050767Orig1s016ltr.pdf
12/20/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf
09/08/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050680Orig1s013,050767Orig1s014ltr.pdf
07/13/2015	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767Orig1s012ltr.pdf
05/09/2014	SUPPL-11	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767Orig1s011ltr.pdf
06/19/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050767s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050767Orig1s010ltr.pdf
05/15/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 050767

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050767Orig1s019lbl.pdf
07/26/2022	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050767Orig1s019lbl.pdf
05/17/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050767s018lbl.pdf
03/23/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050680s018,050767s017lbl.pdf
09/16/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050767s016lbl.pdf
12/20/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf
09/08/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf
07/13/2015	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf
05/09/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf
05/09/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf
06/19/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050767s010lbl.pdf
08/13/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50767lbl.pdf

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