Details for New Drug Application (NDA): 210001
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The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 210001
Tradename: | AZITHROMYCIN |
Applicant: | Bionpharma |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210001
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 210001 | ANDA | AvKARE | 42291-083 | 42291-083-03 | 3 TABLET, FILM COATED in 1 BOTTLE (42291-083-03) |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 210001 | ANDA | AvKARE | 42291-083 | 42291-083-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-083-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Feb 26, 2019 | TE: | AB | RLD: | No |
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