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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050611

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PCE (ERYTHROMYCIN)
333MG
Marketing Status: Discontinued
Active Ingredient: ERYTHROMYCIN
Proprietary Name: PCE
Dosage Form; Route of Administration: TABLET, COATED PARTICLES; ORAL
Strength: 333MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050611
Product Number: 001
Approval Date: Sep 9, 1986
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PCE (ERYTHROMYCIN)
500MG
Marketing Status: Discontinued
Active Ingredient: ERYTHROMYCIN
Proprietary Name: PCE
Dosage Form; Route of Administration: TABLET, COATED PARTICLES; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050611
Product Number: 002
Approval Date: Aug 22, 1990
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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