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MEPROBAMATE

NDA

MEPROBAMATE | N014474 | STANLABS PHARMACEUTICAL CO SUB SIMPAK CORP

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 Chain7 active DMFs8 inactive

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

FAR SPECIALTY PRODUCTS INC DBA FAR CHEMICALMEPROBAMATE

DMF 181932005

SYMED LABS LTDMEPROBAMATE USP

DMF 196782006

SOLARA ACTIVE PHARMA SCIENCES LTDMEPROBAMATE USP

DMF 196802006

ALEMBIC PHARMACEUTICALS LTDMEPROBAMATE USP

DMF 204202007

FORMOSA LABORATORIES INCMEPROBAMATE

DMF 204652007

HARMAN FINOCHEM LTDMEPROBAMATE USP

DMF 206742007

TARO PHARMACEUTICAL INDUSTRIES LTDMEPROBAMATE USP

DMF 232842009

PRODOTTI CHIMICI DOTTORI REInactiveMEPROBAMATE

DMF 4411961

ALFA WASSERMANN SPAInactiveMEPROBAMATE

DMF 4821962

MILAN PHARMACEUTICALS INCInactiveMEPROBAMATE TABLETS

DMF 8981965

WALLACE LABORATORIES DIV CARTER WALLACE INCInactiveMEPROBAMATE POWDER-WITH TRACER

DMF 9031965

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveMEPROBAMATE

DMF 10891967

KEMKO INCInactiveMEPROBAMATE N.F.XII

DMF 12471968

DANISCO ASInactiveMEPROBAMATE

DMF 40921981

ALP PHARM BEIJING CO LTDInactiveMEPROBAMATE (DRUG SUBSTANCE, NON-STERILE)

DMF 224232008

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

Products (2)

Sort:

#002 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982