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Details for New Drug Application (NDA): 050733
The generic ingredient in ZITHROMAX is azithromycin. There are thirty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 050733
Tradename: | ZITHROMAX |
Applicant: | Pfizer |
Ingredient: | azithromycin |
Patents: | 1 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 050733
Ingredient-type | Macrolides |
Medical Subject Heading (MeSH) Categories for 050733
Suppliers and Packaging for NDA: 050733
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZITHROMAX | azithromycin | INJECTABLE;INJECTION | 050733 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0400 | N | 0069-0400-10 |
ZITHROMAX | azithromycin | INJECTABLE;INJECTION | 050733 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-3150 | N | 0069-3150-83 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Jan 30, 1997 | TE: | AP | RLD: | Yes | ||||
Patent: | ➤ Sign Up | Patent Expiration: | Jul 31, 2018 | Product Flag? | Substance Flag? | Y | Delist Request? |
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