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DESONIDE

ANDA

DESONIDE | A202470 | SENORES PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Healthcare Pharmaceuticals, Inc., et al v. River's Edge Pharmaceuticals, LLC et al 1:2011cv01634 1 patentANDA 202470Desonide	GAND	2011-05-19	Terminated 2018-11-15	—

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

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVDESONIDE

DMF 44201982

FARMABIOS SPADESONIDE DRUG SUBSTANCE

DMF 195742006

AARTI PHARMALABS LTDDESONIDE

DMF 229632009

LINSON LTDInactiveDESONIDE

DMF 16711971

ASPEN OSS BVInactiveDESONIDE

DMF 39391980

ER SQUIBB AND SONS INCInactiveDESONIDE

DMF 40081980

NITA PHARMACEUTICAL LTDInactiveDESONIDE (PREDNACINOLONE 16,17 ACETONIDE

DMF 54761984

NEWCHEM SPAInactiveDESONIDE MICRONIZED

DMF 227492009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 6, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: May 11, 2020

No patent or exclusivity listings for this strength.