Assyro AI

Orange Book product · Generic (ANDA)

TRETINOIN

TRETINOIN

Generic (ANDA)ANDA 075265TE AB1RX PADAGIS US

At a glance

Dec 24, 1998

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 24, 1998

    27 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TRETINOIN

Strength

0.05%

Dosage form

CREAM

Route

TOPICAL

TE code

AB1

Application

ANDA 075265

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TRETINOIN

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.