Orange Book product · Brand (NDA)
RETROVIR
ZIDOVUDINE
At a glance
Oct 04, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 04, 1996
30 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ZIDOVUDINE
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020518
Product number
002
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.
- 2011ZIDOVUDINEBrand (NDA)
NDA 200732 · PHARMOBEDIENT
- 2009ZIDOVUDINEBrand (NDA)
NDA 022294 · AUROBINDO PHARMA
- 1990RETROVIRBrand (NDA)
NDA 019951 · VIIV HLTHCARE
- 1989RETROVIRBrand (NDA)
NDA 019910 · VIIV HLTHCARE
- 1987RETROVIRBrand (NDA)
NDA 019655 · VIIV HLTHCARE
- 2013ZIDOVUDINEGeneric (ANDA)
ANDA 204538 · LIAONING CHENGDA
- 2011ZIDOVUDINEGeneric (ANDA)
ANDA 202058 · HEC PHARM
- 2010ZIDOVUDINEGeneric (ANDA)
ANDA 090561 · CIPLA
- 2010ZIDOVUDINEGeneric (ANDA)
ANDA 091457 · AM REGENT
- 2008ZIDOVUDINEGeneric (ANDA)
ANDA 077981 · CIPLA LTD
- 2008ZIDOVUDINEGeneric (ANDA)
ANDA 090092 · HETERO LABS LTD III
- 2008ZIDOVUDINEGeneric (ANDA)
ANDA 078922 · PHARMOBEDIENT
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.
