Product Details for NDA 014713
ETRAFON 2-10 (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: ETRAFON 2-10
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
ETRAFON 2-25 (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
Proprietary Name: ETRAFON 2-10
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: ETRAFON 2-25
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
ETRAFON-A (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
Proprietary Name: ETRAFON 2-25
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: ETRAFON-A
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
ETRAFON-FORTE (AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE)
Proprietary Name: ETRAFON-A
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Proprietary Name: ETRAFON-FORTE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ETRAFON-FORTE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014713
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SCHERING CORP SUB SCHERING PLOUGH CORP
Marketing Status: Discontinued
Patent and Exclusivity Information