Registrants (1)
Dr. Reddys Laboratories, Inc.
802315887
Manufacturing Establishments (2)
Cipla Limited- Indore
Dr. Reddys Laboratories, Inc.
Dr. Reddys Laboratories, Inc.
918596409
Cipla Patalganga
Dr. Reddys Laboratories, Inc.
Dr. Reddys Laboratories, Inc.
916940208
Products (3)
levalbuterol inhalation
43598-409
ANDA078171
ANDA (C73584)
RESPIRATORY (INHALATION)
September 16, 2014
LevosalbutamolActive
Code: EDN2NBH5SSClass: ACTIBQuantity: 1.25 mg in 3 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
Sulfuric AcidInactive
Code: O40UQP6WCFClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
Edetate DisodiumInactive
Code: 7FLD91C86KClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
levalbuterol inhalation
43598-412
ANDA078171
ANDA (C73584)
RESPIRATORY (INHALATION)
September 16, 2014
LevosalbutamolActive
Code: EDN2NBH5SSClass: ACTIBQuantity: 0.31 mg in 3 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
Sulfuric AcidInactive
Code: O40UQP6WCFClass: IACT
Edetate DisodiumInactive
Code: 7FLD91C86KClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
levalbuterol inhalation
43598-410
ANDA078171
ANDA (C73584)
RESPIRATORY (INHALATION)
September 16, 2014
LevosalbutamolActive
Code: EDN2NBH5SSClass: ACTIBQuantity: 0.63 mg in 3 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
Edetate DisodiumInactive
Code: 7FLD91C86KClass: IACT
Sulfuric AcidInactive
Code: O40UQP6WCFClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT