Orange Book product · Brand (NDA)
ZIAGEN
ABACAVIR SULFATE
At a glance
Dec 17, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 1998
27 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ABACAVIR SULFATE
Strength
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020977
Product number
001
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.
- 1998ZIAGENBrand (NDA)
NDA 020978 · VIIV HLTHCARE
- 2018ABACAVIR SULFATEGeneric (ANDA)
ANDA 077950 · AUROBINDO PHARMA LTD
- 2017ABACAVIR SULFATEGeneric (ANDA)
ANDA 078119 · CIPLA
- 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.
