Details for New Drug Application (NDA): 065488
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The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065488
Tradename: | AZITHROMYCIN |
Applicant: | Chartwell Rx |
Ingredient: | azithromycin |
Patents: | 0 |
Suppliers and Packaging for NDA: 065488
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 065488 | ANDA | Chartwell RX, LLC | 62135-704 | 62135-704-51 | 15 mL in 1 BOTTLE (62135-704-51) |
AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 065488 | ANDA | Chartwell RX, LLC | 62135-705 | 62135-705-43 | 30 mL in 1 BOTTLE (62135-705-43) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 100MG BASE/5ML | ||||
Approval Date: | May 15, 2015 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 200MG BASE/5ML | ||||
Approval Date: | May 15, 2015 | TE: | RLD: | No |
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