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Orange Book product · Generic (ANDA)

NYSTATIN AND TRIAMCINOLONE ACETONIDE

NYSTATIN; TRIAMCINOLONE ACETONIDE

Generic (ANDA)ANDA 207380TE ATRX PADAGIS ISRAEL
View NYSTATIN; TRIAMCINOLONE ACETONIDE familyOpen on FDA Orange Book

At a glance

Dec 20, 2016

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 20, 2016

    9 yr 8 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

AT

Application

ANDA 207380

Product number

001

Marketing status

RX

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

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