Details for New Drug Application (NDA): 050582
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NDA 050582 describes DORYX, which is a drug marketed by Mayne Pharma and Warner Chilcott and is included in three NDAs. It is available from one supplier. There are four patents protecting this drug and seven Paragraph IV challenges. Additional details are available on the DORYX profile page.
The generic ingredient in DORYX is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in DORYX is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 050582
| Tradename: | DORYX |
| Applicant: | Mayne Pharma |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jul 22, 1985 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Aug 13, 2001 | TE: | RLD: | Yes | |||||
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