Assyro AI

Orange Book product · Generic (ANDA)

BROMPHERIL

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Generic (ANDA)ANDA 089116DISCN COPLEY PHARM

At a glance

Jan 22, 1987

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 22, 1987

    40 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Strength

6MG;120MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 089116

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

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.