Details for New Drug Application (NDA): 203412
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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 203412
Tradename: | AZITHROMYCIN |
Applicant: | Slate Run Pharma |
Ingredient: | azithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203412
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 203412 | ANDA | Slate Run Pharmaceuticals | 70436-019 | 70436-019-82 | 10 VIAL in 1 BOX (70436-019-82) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Oct 9, 2018 | TE: | AP | RLD: | No |
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