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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

Teva Pharmaceuticals USA, Inc.

DUNS: 001627975

Effective Date

September 30, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tiagabine(4 mg in 1 1)

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

0093-5031

Application Number

NDA020646

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

August 15, 2023

Ingredients

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 4 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918CClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

0093-8072

Application Number

NDA020646

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

August 15, 2023

Ingredients

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918CClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 12 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

0093-8076

Application Number

NDA020646

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

August 15, 2023

Ingredients

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 16 mg in 1 1

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918CClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

0093-5030

Application Number

NDA020646

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

August 15, 2023

Ingredients

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 2 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918CClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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