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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 012703

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ELAVIL (AMITRIPTYLINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE
Proprietary Name: ELAVIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012703
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ELAVIL (AMITRIPTYLINE HYDROCHLORIDE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE
Proprietary Name: ELAVIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012703
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ELAVIL (AMITRIPTYLINE HYDROCHLORIDE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE
Proprietary Name: ELAVIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012703
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ELAVIL (AMITRIPTYLINE HYDROCHLORIDE)
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE
Proprietary Name: ELAVIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012703
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ELAVIL (AMITRIPTYLINE HYDROCHLORIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE
Proprietary Name: ELAVIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012703
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ELAVIL (AMITRIPTYLINE HYDROCHLORIDE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE
Proprietary Name: ELAVIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012703
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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