Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204713

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BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
0.5MG
Marketing Status: Prescription

Active Ingredient: BENZTROPINE MESYLATE
Proprietary Name: BENZTROPINE MESYLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A204713
Product Number: 001
Approval Date: Apr 14, 2015
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
1MG
Marketing Status: Prescription

Active Ingredient: BENZTROPINE MESYLATE
Proprietary Name: BENZTROPINE MESYLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A204713
Product Number: 002
Approval Date: Apr 14, 2015
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
2MG
Marketing Status: Prescription

Active Ingredient: BENZTROPINE MESYLATE
Proprietary Name: BENZTROPINE MESYLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A204713
Product Number: 003
Approval Date: Apr 14, 2015
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information