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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050698

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BIAXIN (CLARITHROMYCIN)
125MG/5ML
Marketing Status: Discontinued
Active Ingredient: CLARITHROMYCIN
Proprietary Name: BIAXIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050698
Product Number: 001
Approval Date: Dec 23, 1993
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
BIAXIN (CLARITHROMYCIN)
187MG/5ML
Marketing Status: Discontinued
Active Ingredient: CLARITHROMYCIN
Proprietary Name: BIAXIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 187MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050698
Product Number: 003
Approval Date: Sep 30, 1998
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
BIAXIN (CLARITHROMYCIN)
250MG/5ML
Marketing Status: Discontinued
Active Ingredient: CLARITHROMYCIN
Proprietary Name: BIAXIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050698
Product Number: 002
Approval Date: Dec 23, 1993
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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