Orange Book product · Brand (NDA)
AUGMENTIN XR
AMOXICILLIN; CLAVULANATE POTASSIUM
At a glance
Sep 25, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2002
24 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Strength
1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 050785
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2001AUGMENTIN ES-600Brand (NDA)
NDA 050755 · US ANTIBIOTICS
- 1996AUGMENTIN '200'Brand (NDA)
NDA 050725 · US ANTIBIOTICS
- 1996AUGMENTIN '200'Brand (NDA)
NDA 050726 · US ANTIBIOTICS
- 1996AUGMENTIN '875'Brand (NDA)
NDA 050720 · US ANTIBIOTICS
- 1985AUGMENTIN '125'Brand (NDA)
NDA 050597 · US ANTIBIOTICS
- 1984AUGMENTIN '125'Brand (NDA)
NDA 050575 · US ANTIBIOTICS
- 1984AUGMENTIN '250'Brand (NDA)
NDA 050564 · US ANTIBIOTICS
- 2023AMOXICILLIN AND CLAVULANATE POTASSIUMGeneric (ANDA)
ANDA 210416 · DEVA HOLDING AS
- 2023AMOXICILLIN AND CLAVULANATE POTASSIUMGeneric (ANDA)
ANDA 217805 · MICRO LABS
- 2023AMOXICILLIN AND CLAVULANATE POTASSIUMGeneric (ANDA)
ANDA 210374 · DEVA HOLDING AS
- 2023AMOXICILLIN AND CLAVULANATE POTASSIUMGeneric (ANDA)
ANDA 209992 · DEVA HOLDING AS
- 2023AMOXICILLIN AND CLAVULANATE POTASSIUMGeneric (ANDA)
ANDA 209991 · DEVA HOLDING AS
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.
