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Orange Book product · Brand (NDA)

Augmentin Es-600

Amoxicillin; Clavulanate Potassium

Brand (NDA)NDA 050755TE ABRLD US Antibiotics
Approved
Jun 22, 2001
Application
Brand (NDA)
TE code
AB
Listed patents
0
Augmentin Es-600 (Amoxicillin; Clavulanate Potassium) is US Antibiotics's brand-name drug, approved by the FDA under NDA 050755 in 2001. 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. 41 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.

    Jun 22, 2001

    25 yr 5 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

AB

Application

NDA 050755

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 Amoxicillin; Clavulanate Potassium 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.

Augmentin Es-600 — 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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