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FDA Approval

COMBIVIR

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 22, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Zidovudine(300 mg in 1 1)
Lamivudine(150 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

COMBIVIR

Product Details

NDC Product Code
49702-202
Application Number
NDA020857
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
April 27, 2018
Code: 4B9XT59T7SClass: ACTIBQuantity: 300 mg in 1 1
Code: 2T8Q726O95Class: ACTIBQuantity: 150 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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