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CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

ANDA

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | A205397 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ACANYA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
DOW PHARMACEUTICAL SCIENCES, INC. et al v. PERRIGO COMPANY et al 2:2013cv06922 1 patentANDA 205397clindamycin phosphate and benzoyl peroxide	D.N.J.	2013-11-15	Terminated 2014-08-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 13, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5%;EQ 1.2% BASE

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Sep 9, 2019

No patent or exclusivity listings for this strength.