Atenolol And Chlorthalidone
Atenolol; Chlorthalidone
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 2020
5 yr 9 mo ago
Today
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
Other strengths in ANDA 213302
Active-ingredient family
Generic (ANDA) of Atenolol; Chlorthalidone
- 1984Tenoretic 100Brand (NDA)
NDA 018760 · Twi Pharms
- 2021Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 215560 · Novitium Pharma
- 2019Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 210028 · Zydus Pharms
- 1998Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 074404 · Nostrum Labs
- 1997Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 074107 · Pliva
- 1993Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 074203 · Aurobindo Pharma USA
- 1993Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 073582 · Sun Pharm Industries
- 1992Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 073665 · Watson Labs
- 1990Atenolol And ChlorthalidoneGeneric (ANDA)
ANDA 072302 · Aiping Pharm Inc
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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

