Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
Aurobindo Pharma Limited
650381903
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
65862-036Application Number
ANDA077558Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 11, 2022LamivudineActive
Code: 2T8Q726O95Class: ACTIBQuantity: 150 mg in 1 1
ZidovudineActive
Code: 4B9XT59T7SClass: ACTIBQuantity: 300 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT