Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Macleods Pharmaceuticals Limited
Macleods Pharmaceuticals Limited
918608365
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamivudine and Zidovudine
Product Details
NDC Product Code
33342-003Application Number
ANDA090679Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 13, 2023ZidovudineActive
Code: 4B9XT59T7SClass: ACTIBQuantity: 300 mg in 1 1
LamivudineActive
Code: 2T8Q726O95Class: ACTIBQuantity: 150 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT