Product Details for NDA 050662
BIAXIN (CLARITHROMYCIN)
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLARITHROMYCIN
Proprietary Name: BIAXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050662
Product Number: 001
Approval Date: Oct 31, 1991
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
BIAXIN (CLARITHROMYCIN)
Proprietary Name: BIAXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050662
Product Number: 001
Approval Date: Oct 31, 1991
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLARITHROMYCIN
Proprietary Name: BIAXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050662
Product Number: 002
Approval Date: Oct 31, 1991
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: BIAXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050662
Product Number: 002
Approval Date: Oct 31, 1991
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information