Orange Book product · Brand (NDA)
AMOXIL
AMOXICILLIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
AMOXICILLIN
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050460
Product number
005
Marketing status
DISCN
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.
- 1999AMOXILBrand (NDA)
NDA 050760 · US ANTIBIOTICS
- —AMOXILBrand (NDA)
NDA 050459 · 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.
