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Orange Book product · Brand (NDA)

Amipaque

Metrizamide

Brand (NDA)NDA 017982Discontinued Ge Healthcare
Approved
Approved Prior to Jan 1, 1982
Application
Brand (NDA)
TE code
Not listed
Listed patents
0
Amipaque (Metrizamide) is Ge Healthcare's brand-name drug, approved by the FDA under NDA 017982. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

METRIZAMIDE

Strength

3.75GM/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 017982

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

No

Reference standard (RS)

No

Same application

Other strengths in NDA 017982

Brand + generics

Active-ingredient family

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

No other applications share this active ingredient.

View full Metrizamide family
Orange Book patent file

Listed patents

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.

Amipaque — frequently asked questions

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

Built directly from the FDA Orange Book data file. This product page links back to the Metrizamide active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

Related FDA reference tools

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