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Orange Book product · Generic (ANDA)

Aspirin And Dipyridamole

Aspirin; Dipyridamole

Generic (ANDA)ANDA 210318TE AB Glenmark Speclt
Approved
May 24, 2019
Application
Generic (ANDA)
TE code
AB
Listed patents
0
Aspirin And Dipyridamole (Aspirin; Dipyridamole) is a generic drug approved under an ANDA (210318) in 2019, marketed by Glenmark Speclt. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 24, 2019

    7 yr 3 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

ASPIRIN; DIPYRIDAMOLE

Strength

25MG;200MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 210318

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.

Aspirin And Dipyridamole — 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 Aspirin; Dipyridamole active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

Related FDA reference tools

Agent CTA Background

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