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Orange Book product · Generic (ANDA)

Atenolol And Chlorthalidone

Atenolol; Chlorthalidone

Generic (ANDA)ANDA 213302TE AB Unichem
Approved
Nov 25, 2020
Application
Generic (ANDA)
TE code
AB
Listed patents
0
Atenolol And Chlorthalidone (Atenolol; Chlorthalidone) is a generic drug approved under an ANDA (213302) in 2020, marketed by Unichem. 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.

    Nov 25, 2020

    5 yr 9 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

ATENOLOL; CHLORTHALIDONE

Strength

100MG;25MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 213302

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Same application

Other strengths in ANDA 213302

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.

Atenolol And Chlorthalidone — 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 Atenolol; Chlorthalidone 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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