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Orange Book product · Brand (NDA)

Atacand HCT

Candesartan Cilexetil; Hydrochlorothiazide

Brand (NDA)NDA 021093TE ABRLD Ani Pharms
Approved
Sep 05, 2000
Application
Brand (NDA)
TE code
AB
Listed patents
0
Atacand HCT (Candesartan Cilexetil; Hydrochlorothiazide) is Ani Pharms's brand-name drug, approved by the FDA under NDA 021093 in 2000. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 6 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 05, 2000

    26 yr 3 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Strength

32MG;12.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 021093

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Same application

Other strengths in NDA 021093

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Candesartan Cilexetil; Hydrochlorothiazide 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.

Atacand HCT — 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 Candesartan Cilexetil; Hydrochlorothiazide active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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