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HALOBETASOL PROPIONATE

ANDA

HALOBETASOL PROPIONATE | A211464 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Sun Pharmaceutical Industries, Inc. et al v. Perrigo Company et al 1:2018cv00530 1 patentANDA 211464halobetasol propionate	MIWD	2018-05-10	Terminated 2018-08-24	—
Sun Pharmaceutical Industries, Inc. et al v. Perrigo Company et al 1:2018cv00703 1 patentANDA 211464halobetasol propionate	D. Del.	2018-05-09	Terminated 2020-03-11	—

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

API Supply Chain7 active DMFs2 inactive

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

WAVELENGTH ENTERPRISES LTDHALOBETASOL PROPIONATE

DMF 168562003

STERLING SPAHALOBETASOL PROPIONATE

DMF 168612003

HOVIONE FARMACIENCIA SAHALOBETASOL PROPIONATE

DMF 169532003

TARO PHARMACEUTICAL INDUSTRIES LTDHALOBETASOL PROPIONATE USP, MICRONIZED

DMF 175292004

TRIFARMA SPAHALOBETASOL PROPIONATE

DMF 185662005

SYMBIOTEC PHARMALAB PRIVATE LTDHALOBETASOL PROPIONATE

DMF 194022006

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDHALOBETASOL PROPIONATE

DMF 309062016

SAFC INCInactiveHALOBETASOL PROPIONATE (HBS)

DMF 163292002

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveHALOBETASOL PROPIONATE

DMF 169442003

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Jun 3, 2020

No patent or exclusivity listings for this strength.