Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207531

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AZITHROMYCIN (AZITHROMYCIN)
EQ 100MG BASE/5ML
Marketing Status: Prescription

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: AB
Application Number: A207531
Product Number: 001
Approval Date: Apr 9, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AZITHROMYCIN (AZITHROMYCIN)
EQ 200MG BASE/5ML
Marketing Status: Prescription

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: AB
Application Number: A207531
Product Number: 002
Approval Date: Apr 9, 2018
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information