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FDA Approval

Benztropine Mesylate

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

FDA Approval Summary

Company

Marlex Pharmaceuticals Inc

DUNS: 782540215

Effective Date

May 22, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Benzatropine(0.5 mg in 1 1)

Products3

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

Benztropine Mesylate

Product Details

NDC Product Code

10135-606

Application Number

ANDA090168

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 17, 2019

Ingredients

BenzatropineActive

Code: WMJ8TL7510Class: ACTIBQuantity: 0.5 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CORN OILInactive

Code: 8470G57WFMClass: IACT

Benztropine Mesylate

Product Details

NDC Product Code

10135-608

Application Number

ANDA090168

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 17, 2019

Ingredients

BenzatropineActive

Code: WMJ8TL7510Class: ACTIBQuantity: 2 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CORN OILInactive

Code: 8470G57WFMClass: IACT

Benztropine Mesylate

Product Details

NDC Product Code

10135-607

Application Number

ANDA090168

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 17, 2019

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

BenzatropineActive

Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CORN OILInactive

Code: 8470G57WFMClass: IACT

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