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Orange Book product · Generic (ANDA)

CLINDAMYCIN PHOSPHATE AND TRETINOIN

CLINDAMYCIN PHOSPHATE; TRETINOIN

Generic (ANDA)ANDA 216943TE AB2RX ENCUBE

At a glance

Sep 01, 2023

Approved

Generic (ANDA)

Application

AB2

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 01, 2023

    2 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLINDAMYCIN PHOSPHATE; TRETINOIN

Strength

1.2%;0.025%

Dosage form

GEL

Route

TOPICAL

TE code

AB2

Application

ANDA 216943

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CLINDAMYCIN PHOSPHATE; 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.