Orange Book product · Generic (ANDA)
ABACAVIR SULFATE
ABACAVIR SULFATE
At a glance
Nov 21, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2017
8 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ABACAVIR SULFATE
Strength
EQ 300MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 078119
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ABACAVIR SULFATE
- 1998ZIAGENBrand (NDA)
NDA 020978 · VIIV HLTHCARE
- 1998ZIAGENBrand (NDA)
NDA 020977 · VIIV HLTHCARE
- 2018ABACAVIR SULFATEGeneric (ANDA)
ANDA 077950 · AUROBINDO PHARMA LTD
- 2016ABACAVIR SULFATEGeneric (ANDA)
ANDA 091050 · CHARTWELL RX
- 2016ABACAVIR SULFATEGeneric (ANDA)
ANDA 201107 · HETERO LABS LTD III
- 2013ABACAVIR SULFATEGeneric (ANDA)
ANDA 091560 · HETERO LABS LTD III
- 2012ABACAVIR SULFATEGeneric (ANDA)
ANDA 201570 · APOTEX INC
- 2012ABACAVIR SULFATEGeneric (ANDA)
ANDA 077844 · AUROBINDO PHARMA LTD
- 2012ABACAVIR SULFATEGeneric (ANDA)
ANDA 091294 · MYLAN PHARMS INC
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.
