Details for New Drug Application (NDA): 216943

NDA 216943 describes CLINDAMYCIN PHOSPHATE AND TRETINOIN, which is a drug marketed by Actavis Mid Atlantic, Encube, and Solaris Pharma Corp, and is included in three NDAs. It is available from three suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE AND TRETINOIN profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE AND TRETINOIN is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for 216943

Tradename:	CLINDAMYCIN PHOSPHATE AND TRETINOIN
Applicant:	Encube
Ingredient:	clindamycin phosphate; tretinoin
Patents:	0

Pharmacology for NDA: 216943

Physiological Effect

Decreased Sebaceous Gland Activity Neuromuscular Blockade

Suppliers and Packaging for NDA: 216943

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	216943	ANDA	Encube Ethicals Private Limited	21922-050	21922-050-05	1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE
CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	216943	ANDA	Encube Ethicals Private Limited	21922-050	21922-050-07	1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1.2%;0.025%
Approval Date:	Sep 1, 2023	TE:	AB2	RLD:	No

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