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MEGACE

NDA

MEGESTROL ACETATE | N020264 | BRISTOL MYERS SQUIBB

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Odan Laboratories, Inc. FDA-2006-P-0457 The document is severely degraded and largely illegible, making it impossible to accurately extract the specific information requested. While the header indicates this petition concerns "Gododan" (Lidocaine Hydrochloride) Non-Aerosol Oral Spray filed by Odan Laboratories, Inc., the corrupted text pr	Other	2008-07-21	Denied	Odan Laboratories

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs7 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCMEGESTROL ACETATE USP

DMF 18171971

FARMABIOS SPAMEGESTROL ACETATE

DMF 126621997

TAPI NL BVMEGESTROL ACETATE

DMF 126871997

TAIZHOU TAIFA PHARMACEUTICALS CO LTDMEGESTROL ACETATE

DMF 245832011

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDMEGESTROL ACETATE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 245922011

JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTDMEGESTROL ACETATE

DMF 275962013

ZHEJIANG XIANJU YANGGUANG BIOPRODUCTS CO LTDMEGESTROL ACETATE

DMF 356012021

SYNTEX USA INCInactiveMEGESTROL ACETATE

DMF 17381971

GLAXO LABORATORIES SAInactiveMEGESTROL ACETATE

DMF 24941975

DIOSYNTH BVInactiveMEGESTROL ACETATE MICRO

DMF 38691980

BAYER SCHERING PHARMA AGInactiveMEGESTROL ACETATE

DMF 52961984

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveMEGESTROL ACETATE

DMF 66731986

DIOSYNTH BVInactiveMEGESTROL ACETATE FROM GRANULATE

DMF 70121987

NV ORGANONInactiveMEGESTROL ACETATE

DMF 121571996

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 19, 2019	SUPPL -21	View Letter (PDF)
Apr 11, 2012	SUPPL -17	View Letter (PDF)
May 30, 2003	SUPPL -11	View Letter (PDF)
Apr 9, 2002	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Sep 10, 1993

No patent or exclusivity listings for this strength.