Assyro AI

Orange Book product · Generic (ANDA)

PASER

AMINOSALICYLIC ACID

Generic (ANDA)ANDA 074346RX ADAPTIS

At a glance

Jun 30, 1994

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 30, 1994

    32 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMINOSALICYLIC ACID

Strength

4GM/PACKET

Dosage form

GRANULE, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 074346

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of AMINOSALICYLIC ACID

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.