Orange Book product · Brand (NDA)

ZIANA

CLINDAMYCIN PHOSPHATE; TRETINOIN

Brand (NDA)NDA 050802TE AB1RX BAUSCH

View CLINDAMYCIN PHOSPHATE; TRETINOIN family Open on FDA Orange Book

At a glance

Nov 07, 2006

Approved

Brand (NDA)

Application

AB1

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 07, 2006
19 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

CLINDAMYCIN PHOSPHATE; TRETINOIN

Strength

1.2%;0.025%

Dosage form

GEL

Route

TOPICAL

TE code

AB1

Application

NDA 050802

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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.

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