Details for New Drug Application (NDA): 065211
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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 065211
Tradename: | AZITHROMYCIN |
Applicant: | Sandoz |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065211
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | TABLET;ORAL | 065211 | ANDA | Sandoz Inc | 0781-8089 | 0781-8089-26 | 6 DOSE PACK in 1 CARTON (0781-8089-26) / 1 TABLET, FILM COATED in 1 DOSE PACK |
AZITHROMYCIN | azithromycin | TABLET;ORAL | 065211 | ANDA | Sandoz Inc | 0781-8089 | 0781-8089-31 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-8089-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Nov 14, 2005 | TE: | AB | RLD: | No |
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