ESCITALOPRAM

Registrants (1)

Graviti Pharmaceuticals Private Limited

DUNS Number

650884781

Manufacturing Establishments (1)

Graviti Pharmaceuticals Private Limited

Labeler

Graviti Pharmaceuticals Private Limited

Registrant

Graviti Pharmaceuticals Private Limited

DUNS Number

650884781

Products (3)

NDC Product Code

69844-034

Application Number

ANDA078777

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 9, 2020

Ingredients

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

EscitalopramActive

Code: 5U85DBW7LOClass: ACTIMQuantity: 10 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ESCITALOPRAM

NDC Product Code

69844-035

Application Number

ANDA078777

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 9, 2020

Ingredients

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

EscitalopramActive

Code: 5U85DBW7LOClass: ACTIMQuantity: 20 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ESCITALOPRAM

NDC Product Code

69844-033

Application Number

ANDA078777

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 9, 2020

Ingredients

EscitalopramActive

Code: 5U85DBW7LOClass: ACTIMQuantity: 5 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

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ESCITALOPRAM

Registrants (1)

Manufacturing Establishments (1)

Products (3)

ESCITALOPRAM

ESCITALOPRAM

ESCITALOPRAM