Assyro AI

Orange Book product · Generic (ANDA)

NICOTINE

NICOTINE

Generic (ANDA)ANDA 074612OTC DIFGEN PHARMS

At a glance

Jul 28, 2003

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 28, 2003

    23 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NICOTINE

Strength

7MG/24HR

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

Not listed

Application

ANDA 074612

Product number

002

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NICOTINE

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.