Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Graviti Pharmaceuticals Private Limited
Graviti Pharmaceuticals Private Limited
Graviti Pharmaceuticals Private Limited
650884781
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
escitalopram
Product Details
NDC Product Code
69844-079Application Number
ANDA078777Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2023EscitalopramActive
Code: 5U85DBW7LOClass: ACTIMQuantity: 20 mg in 1 1
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
escitalopram
Product Details
NDC Product Code
69844-078Application Number
ANDA078777Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2023BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
EscitalopramActive
Code: 5U85DBW7LOClass: ACTIMQuantity: 10 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
escitalopram
Product Details
NDC Product Code
69844-077Application Number
ANDA078777Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2023BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
EscitalopramActive
Code: 5U85DBW7LOClass: ACTIMQuantity: 5 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT