Orange Book product · Brand (NDA)
AMOXIL
AMOXICILLIN
At a glance
Apr 15, 1999
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 1999
27 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
AMOXICILLIN
Strength
400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 050760
Product number
002
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.
- —AMOXILBrand (NDA)
NDA 050459 · GLAXOSMITHKLINE
- —AMOXILBrand (NDA)
NDA 050460 · GLAXOSMITHKLINE
- 2022AMOXICILLINGeneric (ANDA)
ANDA 207471 · MICRO LABS
- 2014AMOXICILLINGeneric (ANDA)
ANDA 204030 · AUROBINDO PHARMA LTD
- 2007AMOXICILLINGeneric (ANDA)
ANDA 065319 · CHARTWELL RX
- 2007AMOXICILLINGeneric (ANDA)
ANDA 065387 · SANDOZ
- 2007AMOXICILLINGeneric (ANDA)
ANDA 065378 · SANDOZ
- 2007AMOXICILLINGeneric (ANDA)
ANDA 065291 · HIKMA PHARMS
- 2006AMOXICILLINGeneric (ANDA)
ANDA 065334 · AUROBINDO
- 2006AMOXICILLINGeneric (ANDA)
ANDA 065322 · HIKMA
- 2006AMOXICILLINGeneric (ANDA)
ANDA 065325 · HIKMA
- 2005AMOXICILLINGeneric (ANDA)
ANDA 065271 · AUROBINDO
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.
