Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Dr. Reddy's Laboratories Limited(FTOIII)
Dr. Reddys Laboratories Limited
918608162
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zafirlukast
Product Details
NDC Product Code
55111-625Application Number
ANDA090372Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 20, 2016hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
ZafirlukastActive
Code: XZ629S5L50Class: ACTIBQuantity: 10 mg in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
polyethylene glycol 400Inactive
Code: B697894SGQClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Zafirlukast
Product Details
NDC Product Code
55111-626Application Number
ANDA090372Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 20, 2016hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
ZafirlukastActive
Code: XZ629S5L50Class: ACTIBQuantity: 20 mg in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polyethylene glycol 400Inactive
Code: B697894SGQClass: IACT