Details for New Drug Application (NDA): 050442
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NDA 050442 describes VIBRAMYCIN, which is a drug marketed by Pfizer and is included in four NDAs. Additional details are available on the VIBRAMYCIN profile page.
The generic ingredient in VIBRAMYCIN is doxycycline calcium. There are twenty-eight drug master file entries for this compound. Additional details are available on the doxycycline calcium profile page.
The generic ingredient in VIBRAMYCIN is doxycycline calcium. There are twenty-eight drug master file entries for this compound. Additional details are available on the doxycycline calcium profile page.
Summary for 050442
| Tradename: | VIBRAMYCIN |
| Applicant: | Pfizer |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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