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Details for New Drug Application (NDA): 050733
NDA 050733 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from eleven suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ZITHROMAX profile page.
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.
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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