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DELALUTIN

NDA

HYDROXYPROGESTERONE CAPROATE | N010347 | BRISTOL MYERS SQUIBB

2 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Custopharm, Inc. FDA-2006-P-0089 Custopharm, Inc. filed this citizen petition under section 705(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA Commissioner determine that Bristol-Myers Squibb's voluntary withdrawal of Delalutin (Hydroxyprogesterone Caproate) Injection, the subject of NDAs 10-347 and 16-	505(q)	2010-07-01	Withdrawn	Custopharm

Source: Regulations.gov. FDA citizen petitions matched by application number.

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 (2)

Sort:

#002 — 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR | Approved: Approved Prior to Jan 1, 1982