Orange Book product · Brand (NDA)
RETROVIR
ZIDOVUDINE
At a glance
Feb 02, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 02, 1990
36 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ZIDOVUDINE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019951
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 1995RETROVIRBrand (NDA)
NDA 020518 · 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.
