Product Details for ANDA 081265
BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
0.5MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
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: No
TE Code: AA
Application Number: A081265
Product Number: 003
Approval Date: Nov 29, 2023
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
Proprietary Name: BENZTROPINE MESYLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A081265
Product Number: 003
Approval Date: Nov 29, 2023
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: No
TE Code: AA
Application Number: A081265
Product Number: 002
Approval Date: Jan 23, 1992
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
Proprietary Name: BENZTROPINE MESYLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A081265
Product Number: 002
Approval Date: Jan 23, 1992
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: No
TE Code: AA
Application Number: A081265
Product Number: 001
Approval Date: Jan 23, 1992
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: BENZTROPINE MESYLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A081265
Product Number: 001
Approval Date: Jan 23, 1992
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information