Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
Rebel Distributors Corp
118802834
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
21695-996Application Number
ANDA079081Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 26, 2010HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
LamivudineActive
Code: 2T8Q726O95Class: ACTIBQuantity: 150 mg in 1 1
ZidovudineActive
Code: 4B9XT59T7SClass: ACTIBQuantity: 300 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT