Assyro AI

Orange Book product · Brand (NDA)

SUTAB

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE

Brand (NDA)NDA 213135TE ABRX AZURITY

At a glance

Nov 10, 2020

Approved

Brand (NDA)

Application

AB

TE code

4

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 10, 2020

    5 yr 8 mo ago

  2. Today

  3. Patent 10143656 expires

    Listed drug product patent expiration.

    Aug 04, 2037

    in 11 yr 3 mo

  4. Patent 11033498 expires

    Listed method-of-use patent (U-3164) expiration.

    Aug 04, 2037

    in 11 yr 3 mo

  5. Patent 11382864 expires

    Listed method-of-use patent (U-3164) expiration.

    Aug 04, 2037

    in 11 yr 3 mo

  6. Patent 11638697 expires

    Listed drug product patent expiration.

    Aug 04, 2037

    in 11 yr 3 mo

Pharmaceutical detail

Active ingredient

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE

Strength

0.225GM;0.188GM;1.479GM

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 213135

Product number

001

Marketing status

RX

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 (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10143656Aug 04, 2037in 11 yr 3 mo
Product
11033498Aug 04, 2037in 11 yr 3 mo
U-3164
11382864Aug 04, 2037in 11 yr 3 mo
U-3164
11638697Aug 04, 2037in 11 yr 3 mo
Product
Agent CTA Background

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