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Details for New Drug Application (NDA): 050711
NDA 050711 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from fourteen 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. Fifty-seven 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. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 050711
| Tradename: | ZITHROMAX |
| Applicant: | Pfizer |
| Ingredient: | azithromycin |
| Patents: | 1 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 050711
| Ingredient-type | Macrolides |
Medical Subject Heading (MeSH) Categories for 050711
Suppliers and Packaging for NDA: 050711
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZITHROMAX | azithromycin | TABLET;ORAL | 050711 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-3060 | N | 0069-3060-30 |
| ZITHROMAX | azithromycin | TABLET;ORAL | 050711 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-3060 | N | 0069-3060-75 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Jul 18, 1996 | TE: | AB | RLD: | Yes | ||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Jul 31, 2018 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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