Is Amoxicillin And Clavulanate Potassium still available?

Yes. Amoxicillin And Clavulanate Potassium (ANDA 065089) is listed with marketing status Prescription in the FDA Orange Book.

What is Amoxicillin And Clavulanate Potassium a generic of?

Amoxicillin And Clavulanate Potassium is a generic (ANDA 065089) containing Amoxicillin; Clavulanate Potassium. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Amoxicillin And Clavulanate Potassium's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Amoxicillin And Clavulanate Potassium substitutable for its reference brand with no expected difference in clinical effect.

What is Amoxicillin And Clavulanate Potassium's FDA application number?

Amoxicillin And Clavulanate Potassium is approved under ANDA 065089, held by Teva.

Orange Book product · Generic (ANDA)

Amoxicillin And Clavulanate Potassium

Amoxicillin; Clavulanate Potassium

Generic (ANDA)ANDA 065089TE AB Teva

Approved

May 25, 2004

Application

Generic (ANDA)

TE code

Listed patents

Amoxicillin And Clavulanate Potassium (Amoxicillin; Clavulanate Potassium) is a generic drug approved under an ANDA (065089) in 2004, marketed by Teva. 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

Approval
FDA approval date of this drug product.
May 25, 2004
22 yr 5 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Strength

400MG/5ML;EQ 57MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Application

ANDA 065089

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Same application

Other strengths in ANDA 065089

200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION

Brand + generics

Active-ingredient family

Generic (ANDA) of Amoxicillin; Clavulanate Potassium

View full Amoxicillin; Clavulanate Potassium family

Orange Book patent file

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.

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

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