Details for New Drug Application (NDA): 211521
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The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 211521
Tradename: | AZITHROMYCIN |
Applicant: | Taro |
Ingredient: | azithromycin |
Patents: | 0 |
Suppliers and Packaging for NDA: 211521
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 211521 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4200 | 51672-4200-3 | 1 BOTTLE in 1 CARTON (51672-4200-3) / 30 mL in 1 BOTTLE |
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 211521 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4200 | 51672-4200-5 | 1 BOTTLE in 1 CARTON (51672-4200-5) / 15 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 200MG BASE/5ML | ||||
Approval Date: | Dec 11, 2019 | TE: | RLD: | No |
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