Product Details for NDA 050495
AMIKIN (AMIKACIN SULFATE)
EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 250MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMIKACIN SULFATE
Proprietary Name: AMIKIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050495
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
AMIKIN (AMIKACIN SULFATE)
Proprietary Name: AMIKIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050495
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 250MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMIKACIN SULFATE
Proprietary Name: AMIKIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 250MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050495
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: AMIKIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 250MG BASE/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: N050495
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information