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NDA

FAMOTIDINE | N020752 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain17 active DMFs9 inactive

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

ASTELLAS IRELAND CO LTDFAMOTIDINE

DMF 73561988

QUIMICA SINTETICA SAFAMOTIDINE

DMF 130361998

ERCROS SAFAMOTIDINE

DMF 130861998

DR REDDYS LABORATORIES LTDFAMOTIDINE USP

DMF 143091999

ZYDUS LIFESCIENCES LTDFAMOTIDINE USP

DMF 185242005

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)FAMOTIDINE USP

DMF 199112006

SMS PHARMACEUTICALS LTDFAMOTIDINE USP

DMF 214422008

ALEMBIC PHARMACEUTICALS LTDFAMOTIDINE USP

DMF 255812011

AZICO BIOPHORE INDIA PVT LTDFAMOTIDINE

DMF 355922021

HETERO DRUGS LTDFAMOTIDINE

DMF 356782021

MSN LIFE SCIENCES PRIVATE LTDFAMOTIDINE USP

DMF 356842021

NAKODA CHEMICALS LTDFAMOTIDINE USP

DMF 362952021

ORCHEV PHARMA PVT LTDFAMOTIDINE USP

DMF 367642022

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDFAMOTIDINE “YUNG SHIN”

DMF 368702022

MAHI DRUGS PRIVATE LTDFAMOTIDINE USP

DMF 374722023

APITORIA PHARMA PRIVATE LTDFAMOTIDINE USP

DMF 386432023

SMS LIFESCIENCES INDIA LTDFAMOTIDINE USP

DMF 389102023

ASTELLAS PHARMA INCInactiveFAMOTIDINE

DMF 57461985

DELMAR CHEMICALS INCInactiveFAMOTIDINE

DMF 81771989

QUIMICA SINTETICA SAInactiveFAMOTIDINE

DMF 90841991

WOCKHARDT LTDInactiveFAMOTIDINE USP

DMF 145301999

SREENIVASA PHARMA PRIVATE LTDInactiveFAMOTIDINE DRUG SUBSTANCE

DMF 152462001

APOTEX PHARMACHEM INCInactiveFAMOTIDINE USP

DMF 182542005

TONIRA PHARMA LTDInactiveFAMOTIDINE

DMF 193832006

DR REDDYS LABORATORIES LTDInactiveFamotidine (Form-A) USP

DMF 210422007

RICHTER THEMIS MEDICARE I PVT LTDInactiveFAMOTIDINE

DMF 248122011

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 6, 2002	SUPPL -5	View Letter (PDF)
May 28, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 28, 1998

No patent or exclusivity listings for this strength.

#002 — 40MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 28, 1998