Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050710

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

Active Ingredient: AZITHROMYCIN
Proprietary Name: ZITHROMAX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 100MG BASE/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050710
Product Number: 001
Approval Date: Oct 19, 1995
Applicant Holder Full Name: PFIZER CHEMICALS DIV PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AZITHROMYCIN
Proprietary Name: ZITHROMAX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 200MG BASE/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050710
Product Number: 002
Approval Date: Oct 19, 1995
Applicant Holder Full Name: PFIZER CHEMICALS DIV PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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