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Details for New Drug Application (NDA): 050795
NDA 050795 describes DORYX MPC, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DORYX MPC profile page.
The generic ingredient in DORYX MPC is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in DORYX MPC is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 050795
| Tradename: | DORYX MPC |
| Applicant: | Mayne Pharma |
| Ingredient: | doxycycline hyclate |
| Patents: | 5 |
| Therapeutic Class: | Antibacterials Dental and Oral Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 050795
| Ingredient-type | Tetracyclines |
Suppliers and Packaging for NDA: 050795
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795 | NDA | Mayne Pharma Inc. | 51862-557 | N | 51862-557-12 |
| DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795 | NDA | Mayne Pharma Inc. | 51862-557 | N | 51862-557-00 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | May 6, 2005 | TE: | AB | RLD: | Yes | ||||
| Patent: | ➤ Sign Up | Patent Expiration: | Dec 15, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Feb 3, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | May 6, 2005 | TE: | AB | RLD: | Yes | ||||
| Patent: | ➤ Sign Up | Patent Expiration: | Dec 15, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET | ||||||||
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