DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 050795
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 |
Complete Access Available with Subscription