Details for New Drug Application (NDA): 211147
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The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 211147
Tradename: | AZITHROMYCIN |
Applicant: | Zydus |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211147
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 211147 | ANDA | A-S Medication Solutions | 50090-4458 | 50090-4458-0 | 1 BOTTLE in 1 CARTON (50090-4458-0) / 30 mL in 1 BOTTLE |
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 211147 | ANDA | A-S Medication Solutions | 50090-4458 | 50090-4458-1 | 30 CASE in 1 BOTTLE (50090-4458-1) / 24 mL in 1 CASE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/5ML | ||||
Approval Date: | Jul 31, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 200MG BASE/5ML | ||||
Approval Date: | Jul 31, 2018 | TE: | AB | RLD: | No |
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