Product Details for NDA 016636
NARCAN (NALOXONE HYDROCHLORIDE)
0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: NARCAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016636
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ADAPT PHARMA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
NARCAN (NALOXONE HYDROCHLORIDE)
Proprietary Name: NARCAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016636
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ADAPT PHARMA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: NARCAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016636
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ADAPT PHARMA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
NARCAN (NALOXONE HYDROCHLORIDE)
Proprietary Name: NARCAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.4MG/ML **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: N016636
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ADAPT PHARMA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: NARCAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML **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: N016636
Product Number: 003
Approval Date: Jun 14, 1982
Applicant Holder Full Name: ADAPT PHARMA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: NARCAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML **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: N016636
Product Number: 003
Approval Date: Jun 14, 1982
Applicant Holder Full Name: ADAPT PHARMA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information