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FDA Approval

Tiagabine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Effective Date

December 30, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tiagabine(2 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Amneal Pharmaceuticals Private Limited

Labeler

Amneal Pharmaceuticals NY LLC

DUNS Number

650762060

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tiagabine Hydrochloride

Product Details

NDC Product Code

69238-1104

Application Number

ANDA208181

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 30, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 2 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

69238-1106

Application Number

ANDA208181

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 30, 2023

Ingredients

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 12 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

69238-1107

Application Number

ANDA208181

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 30, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 16 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

69238-1105

Application Number

ANDA208181

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 30, 2023

Ingredients

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 4 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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