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HYDROXYPROGESTERONE CAPROATE

NDA

HYDROXYPROGESTERONE CAPROATE | N018004 | EPIC PHARMA LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs5 inactive

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

ASPEN OSS BVHYDROXYPROGESTERONE CAPROATE

DMF 171132004

SUN PHARMACEUTICAL INDUSTRIES LTDHYDROXYPROGESTERONE CAPROATE USP

DMF 289582015

SYMBIOTEC PHARMALAB PRIVATE LTDHYDROXYPROGESTERONE CAPROATE USP

DMF 307472016

STEROID SPAHYDROXYPROGESTERONE CAPROATE

DMF 313372017

UPJOHN COInactiveHYDROXYPROGESTERONE CAPROATE

DMF 28561977

DIOSYNTH BVInactiveHYDROXYPROGESTERONE CAPROATE

DMF 29931977

DIOSYNTH BVInactiveHYDROXYPROGESTERONE CAPROATE

DMF 38451980

SCHERING AGInactiveHYDROXYPROGESTERONE CAPROATE

DMF 53181984

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCInactiveHYDROXYPROGESTERONE CAPROATE USP

DMF 325262018

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

Products (1)

#001 — 125MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.