BENZTROPINE MESYLATE

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Bayshore Pharmaceuticals LLC (NJ)

DUNS Number

968737416

Manufacturing Establishments1

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

Leading Pharma, LLC

Labeler

Bayshore Pharmaceuticals LLC (NJ)

Registrant

Bayshore Pharmaceuticals LLC (NJ)

DUNS Number

079575060

Products3

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

Product Details

NDC Product Code

76385-104

Application Number

ANDA090168

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 14, 2019

Ingredients

BenzatropineActive

Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CORN OILInactive

Code: 8470G57WFMClass: IACT