Assyro AI

Orange Book product · Brand (NDA)

HABITROL

NICOTINE

Brand (NDA)NDA 020076OTC DR REDDYS LABS SA
View NICOTINE familyOpen on FDA Orange Book

At a glance

Nov 12, 1999

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 12, 1999

    27 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

NICOTINE

Strength

7MG/24HR

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 020076

Product number

004

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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

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