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DIMETANE

NDA

BROMPHENIRAMINE MALEATE | N010799 | WYETH CONSUMER HEALTHCARE

3 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 Chain3 active DMFs6 inactive

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

KESHAVA ORGANICS PVT LTDBROMPHENIRAMINE MALEATE

DMF 216622008

SIGMA ALDRICH IRELAND LTDBROMPHENIRAMINE MALEATE

DMF 225402009

SUPRIYA LIFESCIENCE LTDBROMPHENIRAMINE MALEATE

DMF 235112010

LOFTUS BRYAN CHEMICALS LTDInactiveBROMPHENIRAMINE MALEATE

DMF 49381983

BOEHRINGER INGELHEIM CHEMICALS INCInactiveBROMPHENIRAMINE MALEATE

DMF 60241985

HEXAGON LABORATORIES INCInactiveBROMPHENIRAMINE MALEATE USP

DMF 65711986

PENCO OF LYNDHURST INCInactiveBROMPHENIRAMINE MALEATE

DMF 78801989

LC UNITED CHEMICAL CORPInactiveBROMPHENIRAMINE

DMF 157112001

GRANULES INDIA LTDInactiveBROMPHENIRAMINE MALEATE USP

DMF 206042007

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

Products (3)

Sort:

#003 — 4MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#010 — 8MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 10, 1983

#011 — 12MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 10, 1983