Assyro AI

Orange Book product · Brand (NDA)

TUXARIN ER

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

Brand (NDA)NDA 206323RX MAINPOINTE

At a glance

Jun 22, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 22, 2015

    11 yr 2 mo ago

  2. Today

  3. Patent 9066942 expires

    Listed method-of-use patent (U-1716) expiration.

    Jan 03, 2032

    in 5 yr 7 mo

  4. Patent 9107921 expires

    Listed drug product patent expiration.

    Jan 03, 2032

    in 5 yr 7 mo

Pharmaceutical detail

Active ingredient

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

Strength

8MG;54.3MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 206323

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9066942Jan 03, 2032in 5 yr 7 mo
U-1716
9107921Jan 03, 2032in 5 yr 7 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.