Details for New Drug Application (NDA): 065511
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The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065511
Tradename: | AZITHROMYCIN |
Applicant: | Hospira |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065511
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 065511 | ANDA | Hospira, Inc. | 0409-0144 | 0409-0144-11 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-21) |
AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 065511 | ANDA | Hospira, Inc. | 0409-0144 | 0409-0144-10 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Jun 26, 2009 | TE: | AP | RLD: | No |
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