MedPath
FDA Approval

RETROVIR

June 15, 2023

HUMAN PRESCRIPTION DRUG LABEL

Zidovudine(100 mg in 1 1)

Products (3)

RETROVIR

49702-211

NDA019655

NDA (C73594)

ORAL

November 5, 2020

STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: 4B9XT59T7SClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

RETROVIR

49702-212

NDA019910

NDA (C73594)

ORAL

November 5, 2020

SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
Code: 4B9XT59T7SClass: ACTIBQuantity: 10 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

RETROVIR

49702-213

NDA019951

NDA (C73594)

INTRAVENOUS

November 5, 2020

Code: 4B9XT59T7SClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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