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 one supplier. There are four 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: | 4 |
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 Commercial LLC | 51862-558 | 51862-558-00 | 3 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-558-00) |
| DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795 | NDA | Mayne Pharma Commercial LLC | 51862-558 | 51862-558-00 | 3 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-558-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | May 6, 2005 | TE: | RLD: | Yes | |||||
| Patent: | 8,715,724 | Patent Expiration: | Feb 3, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 6, 2005 | TE: | RLD: | Yes | |||||
| Patent: | 8,715,724 | Patent Expiration: | Feb 3, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jun 20, 2008 | TE: | RLD: | Yes | |||||
| Patent: | 8,715,724 | Patent Expiration: | Feb 3, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 050795
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-003 | Jun 20, 2008 | 6,958,161 | ⤷ Subscribe |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-006 | Dec 19, 2014 | 6,958,161 | ⤷ Subscribe |
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | 6,958,161 | ⤷ Subscribe |
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-008 | May 20, 2016 | 6,958,161 | ⤷ Subscribe |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-005 | Apr 11, 2013 | 6,958,161 | ⤷ Subscribe |
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