Orange Book product · Brand (NDA)
RETROVIR
ZIDOVUDINE
At a glance
Mar 19, 1987
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 19, 1987
39 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ZIDOVUDINE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 019655
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
- 1990RETROVIRBrand (NDA)
NDA 019951 · VIIV HLTHCARE
- 1989RETROVIRBrand (NDA)
NDA 019910 · 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.
