Assyro AI

Orange Book product · Generic (ANDA)

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Generic (ANDA)ANDA 078366RX DR REDDYS LABS LTD

At a glance

Apr 26, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 26, 2011

    15 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Strength

5MG;240MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 078366

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of DESLORATADINE; 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.