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Orange Book product · Generic (ANDA)

NYSTATIN AND TRIAMCINOLONE ACETONIDE

NYSTATIN; TRIAMCINOLONE ACETONIDE

Generic (ANDA)ANDA 208287DISCN PAI HOLDINGS PHARM

At a glance

Dec 30, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 30, 2016

    9 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Strength

100,000 UNITS/GM;0.1%

Dosage form

OINTMENT

Route

TOPICAL

TE code

Not listed

Application

ANDA 208287

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NYSTATIN; TRIAMCINOLONE ACETONIDE

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.