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Details for New Drug Application (NDA): 050795
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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-eight drug master file entries for this compound. Seventy-four 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-eight drug master file entries for this compound. Seventy-four 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 |
| Formulation / Manufacturing: | see details |
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 | 51862-557-12 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-12) |
| DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795 | NDA | Mayne Pharma Inc. | 51862-557 | 51862-557-12 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-12) |
Paragraph IV (Patent) Challenges for 050795
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2017-09-28 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2017-09-28 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-11-05 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-11-05 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-07-01 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-07-01 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2014-05-19 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2014-05-19 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2008-12-19 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2008-12-19 |
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: | Start Trial | 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: | Start Trial | 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: | Start Trial | 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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