Assyro AI

Orange Book product · Generic (ANDA)

LINDANE

LINDANE

Generic (ANDA)ANDA 088190DISCN WOCKHARDT BIO AG

At a glance

Aug 16, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 16, 1984

    42 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LINDANE

Strength

1%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

ANDA 088190

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LINDANE

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.