Assyro AI

Orange Book product · Brand (NDA)

ZURAGARD

ISOPROPYL ALCOHOL

Brand (NDA)NDA 210872OTC ZUREX PHARMA

At a glance

Apr 26, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

5

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 26, 2019

    7 yr 3 mo ago

  2. Today

  3. Patent 8703828 expires

    Listed drug product patent expiration.

    May 23, 2028

    in 1 yr 11 mo

  4. Patent 9629368 expires

    Listed method-of-use patent (U-1397) expiration.

    May 23, 2028

    in 1 yr 11 mo

  5. Patent 8389583 expires

    Listed method-of-use patent (U-1397) expiration.

    Aug 09, 2029

    in 3 yr 2 mo

  6. Patent 10688291 expires

    Listed drug product patent expiration.

    Dec 20, 2034

    in 8 yr 8 mo

  7. Patent 9844654 expires

    Listed drug product patent expiration.

    Apr 24, 2036

    in 10 yr

Pharmaceutical detail

Active ingredient

ISOPROPYL ALCOHOL

Strength

70%

Dosage form

SOLUTION

Route

TOPICAL

TE code

Not listed

Application

NDA 210872

Product number

001

Marketing status

OTC

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 (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8703828May 23, 2028in 1 yr 11 mo
Product
9629368May 23, 2028in 1 yr 11 mo
U-1397
8389583Aug 09, 2029in 3 yr 2 mo
U-1397
10688291Dec 20, 2034in 8 yr 8 mo
ProductU-1397
9844654Apr 24, 2036in 10 yr
ProductU-1397
Agent CTA Background

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