Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050162
Company: PFIZER

Products on NDA 50162

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 050162

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2022	SUPPL-104	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050162s104lbl.pdf
03/09/2020	SUPPL-102	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050162s102lbl.pdf
06/13/2019	SUPPL-101	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050162s101lbl.pdf
03/15/2018	SUPPL-100	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050162s100lbl.pdf
05/02/2017	SUPPL-99	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf
05/02/2017	SUPPL-98	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050162s098s099lbl.pdf
03/23/2016	SUPPL-96	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf
03/23/2016	SUPPL-95	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf
06/26/2014	SUPPL-93	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf
06/26/2014	SUPPL-92	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf
11/20/2009	SUPPL-85	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050162s085lbl.pdf
09/29/2004	SUPPL-82	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf