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Orange Book product · Generic (ANDA)

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Generic (ANDA)ANDA 214201TE AARX ANDA REPOSITORY

At a glance

Jun 27, 2022

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 27, 2022

    4 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Strength

66%;10%

Dosage form

SOLUTION

Route

ORAL, RECTAL

TE code

AA

Application

ANDA 214201

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

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

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