Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210163

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PERPHENAZINE (PERPHENAZINE)
2MG
Marketing Status: Prescription

Active Ingredient: PERPHENAZINE
Proprietary Name: PERPHENAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210163
Product Number: 001
Approval Date: May 18, 2022
Applicant Holder Full Name: APPCO PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PERPHENAZINE (PERPHENAZINE)
4MG
Marketing Status: Prescription

Active Ingredient: PERPHENAZINE
Proprietary Name: PERPHENAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210163
Product Number: 002
Approval Date: May 18, 2022
Applicant Holder Full Name: APPCO PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PERPHENAZINE (PERPHENAZINE)
8MG
Marketing Status: Prescription

Active Ingredient: PERPHENAZINE
Proprietary Name: PERPHENAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210163
Product Number: 003
Approval Date: May 18, 2022
Applicant Holder Full Name: APPCO PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PERPHENAZINE (PERPHENAZINE)
16MG
Marketing Status: Prescription

Active Ingredient: PERPHENAZINE
Proprietary Name: PERPHENAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210163
Product Number: 004
Approval Date: May 18, 2022
Applicant Holder Full Name: APPCO PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information