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Orange Book product · Generic (ANDA)

BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE

Generic (ANDA)ANDA 088626DISCN WOCKHARDT

At a glance

Oct 12, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 12, 1984

    42 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE

Strength

12.5MG/5ML;10MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 088626

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.