Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205397
Company: PADAGIS ISRAEL

Products on ANDA 205397

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205397

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205397Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205397

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

GEL;TOPICAL; 2.5%;EQ 1.2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACANYA	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	Yes	AB	050819	BAUSCH
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	205128	ACTAVIS LABS UT INC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	205397	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	206575	TARO