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Orange Book drug · Generic (ANDA)

Nystatin And Triamcinolone Acetonide

Nystatin; Triamcinolone Acetonide

ANDA 062364 Sun Pharma Canada
Approved
Dec 22, 1987
Strengths
1
Listed patents
0
Applications
31

What does the FDA Orange Book show for Nystatin And Triamcinolone Acetonide?

Nystatin And Triamcinolone Acetonide contains Nystatin; Triamcinolone Acetonide and appears in 31 FDA Orange Book applications. ANDA 062364 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
31; lead ANDA 062364

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Sun Pharma Canada Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AT

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
0

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001100,000 UNITS/GM;0.1%CREAMTOPICALPrescriptionAT
RS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Sun Pharma Canada Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 062364.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AT across rated presentations

An AT code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

11 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

ANDA 062364 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Cream · Topical

Nystatin; Triamcinolone Acetonide

21 applications
Product rows
21
Active applications
9
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-062364

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

ANDA 062364
TE ATRS
Strength
100,000 UNITS/GM;0.1%
Dosage form
CREAM
Route
TOPICAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    39 yr 2 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Strength

100,000 UNITS/GM;0.1%

Dosage form

CREAM

Route

TOPICAL

TE code

AT

Application

ANDA 062364

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

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.

Other FDA applications for Nystatin And Triamcinolone Acetonide

30 additional filings · 30 generic

The FDA has approved 31 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Nystatin And Triamcinolone Acetonide, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 063305Sun Pharma CanadaMar 29, 19931ATPrescription
ANDA 062186Perrigo New YorkJun 06, 19851—Discontinued
ANDA 062280Perrigo New YorkOct 10, 19851—Discontinued
ANDA 062347Sun Pharma CanadaMar 30, 19871—Discontinued
ANDA 062599Fougera Pharms IncOct 08, 19851ATPrescription
ANDA 062602Fougera Pharms IncOct 09, 19851ATPrescription
ANDA 062656PharmafairJul 30, 19861—Discontinued
ANDA 062657PharmafairJul 30, 19861—Discontinued
ANDA 063010Alpharma US PharmsDec 20, 19881—Discontinued
ANDA 206785RisingDec 29, 20161ATPrescription
ANDA 207217Epic Pharma LLCAug 04, 20171ATPrescription
ANDA 207316Chartwell RxNov 18, 20191—Discontinued
ANDA 207380Padagis IsraelDec 20, 20161ATPrescription
ANDA 207730Crown Labs IncDec 26, 20171ATPrescription
ANDA 207731Crown Labs IncDec 26, 20171—Discontinued
ANDA 207741DR ReddysJan 31, 20171ATPrescription
ANDA 207764Zydus LifesciencesNov 08, 20181ATPrescription
ANDA 208136Glenmark Pharms LtdOct 24, 20161—Discontinued
ANDA 208205LupinMay 31, 20181ATPrescription
ANDA 208287Pai Holdings PharmDec 30, 20161—Discontinued
ANDA 208300Glenmark Pharms LtdJun 23, 20161—Discontinued
ANDA 208326Chartwell RxOct 26, 20161ATPrescription
ANDA 208479Padagis IsraelAug 14, 20171ATPrescription
ANDA 209990AmnealFeb 15, 20181ATPrescription
ANDA 210077Strides PharmaJan 29, 20181—Discontinued
ANDA 213142TorrentJul 14, 20201—Discontinued
ANDA 214090AlembicMar 31, 20211ATPrescription
ANDA 214181Macleods Pharms LtdJul 13, 20221ATPrescription
ANDA 214186AlembicMar 04, 20221ATPrescription
ANDA 214751Macleods Pharms LtdAug 17, 20211ATPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Nystatin; Triamcinolone Acetonide

View full Nystatin; Triamcinolone Acetonide family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Nystatin And Triamcinolone Acetonide: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of ANDA 062364 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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