Details for New Drug Application (NDA): 050805
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NDA 050805 describes ORACEA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ORACEA profile page.
The generic ingredient in ORACEA is doxycycline. There are twenty-eight drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
The generic ingredient in ORACEA is doxycycline. There are twenty-eight drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
Summary for 050805
| Tradename: | ORACEA |
| Applicant: | Galderma Labs Lp |
| Ingredient: | doxycycline |
| Patents: | 1 |
Suppliers and Packaging for NDA: 050805
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORACEA | doxycycline | CAPSULE;ORAL | 050805 | NDA | Galderma Laboratories, L.P. | 0299-3822 | 0299-3822-30 | 30 CAPSULE in 1 BOTTLE (0299-3822-30) |
| ORACEA | doxycycline | CAPSULE;ORAL | 050805 | NDA AUTHORIZED GENERIC | Mayne Pharma Inc. | 68308-668 | 68308-668-30 | 30 CAPSULE in 1 BOTTLE (68308-668-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | May 26, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,749,532 | Patent Expiration: | Dec 19, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA | ||||||||
Expired US Patents for NDA 050805
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 8,394,406 | ⤷ Get Started Free |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 10,058,564 | ⤷ Get Started Free |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 7,232,572 | ⤷ Get Started Free |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 8,206,740 | ⤷ Get Started Free |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 9,241,946 | ⤷ Get Started Free |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 8,394,405 | ⤷ Get Started Free |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 7,211,267 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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