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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065488

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AZITHROMYCIN (AZITHROMYCIN)
EQ 100MG BASE/5ML
Marketing Status: Discontinued
Active Ingredient: AZITHROMYCIN
Proprietary Name: AZITHROMYCIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 100MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065488
Product Number: 001
Approval Date: May 15, 2015
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AZITHROMYCIN (AZITHROMYCIN)
EQ 200MG BASE/5ML
Marketing Status: Discontinued
Active Ingredient: AZITHROMYCIN
Proprietary Name: AZITHROMYCIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 200MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065488
Product Number: 002
Approval Date: May 15, 2015
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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