Product Details for NDA 006134
DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
10MG/30ML
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG/30ML
Marketing Status: Discontinued
Active Ingredient: METHADONE HYDROCHLORIDE
Proprietary Name: DOLOPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/30ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N006134
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
Proprietary Name: DOLOPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/30ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N006134
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHADONE HYDROCHLORIDE
Proprietary Name: DOLOPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N006134
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
Proprietary Name: DOLOPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N006134
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHADONE HYDROCHLORIDE
Proprietary Name: DOLOPHINE HYDROCHLORIDE
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: N006134
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DOLOPHINE HYDROCHLORIDE
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: N006134
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information