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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

BROMPHENIRAMINE MALEATE

ANDA

Tentative Approval

BROMPHENIRAMINE MALEATE | A085521 | PHOENIX LABS NY

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 (1)

#001 — 4MG

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Tablet; Oral | Approved: N/A

No patent or exclusivity listings for this strength.