Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050810

AZASITE (AZITHROMYCIN)
1% Marketing Status: Prescription

Active Ingredient: AZITHROMYCIN
Proprietary Name: AZASITE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050810
Product Number: 001
Approval Date: Apr 27, 2007
Applicant Holder Full Name: OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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