Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202440
Company: PADAGIS ISRAEL

Products on ANDA 202440

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202440

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202440Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 202440

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

GEL;TOPICAL; 5%;EQ 1% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB	209252	GLENMARK PHARMS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB	065443	MYLAN PHARMS INC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB	202440	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB	208776	TARO