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Orange Book product · Generic (ANDA)

Amrinone Lactate

Inamrinone Lactate

Generic (ANDA)ANDA 075513 Hikma
Approved
May 09, 2000
Application
Generic (ANDA)
TE code
Not listed
Listed patents
0
Amrinone Lactate (Inamrinone Lactate) is a generic drug approved under an ANDA (075513) in 2000, marketed by Hikma.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 09, 2000

    26 yr 7 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

INAMRINONE LACTATE

Strength

EQ 5MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 075513

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Brand + generics

Active-ingredient 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.

Amrinone Lactate — 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 Inamrinone Lactate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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