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Details for New Drug Application (NDA): 022185
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NDA 022185 describes TACLONEX, which is a drug marketed by Leo Pharma As and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TACLONEX profile page.
The generic ingredient in TACLONEX is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
The generic ingredient in TACLONEX is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 022185
| Tradename: | TACLONEX |
| Applicant: | Leo Pharma As |
| Ingredient: | betamethasone dipropionate; calcipotriene |
| Patents: | 2 |
Pharmacology for NDA: 022185
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 022185
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185 | NDA | LEO Pharma Inc. | 50222-501 | 50222-501-06 | 40 CARTON in 1 CASE (50222-501-06) > 1 BOTTLE in 1 CARTON > 60 g in 1 BOTTLE |
| TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185 | NDA | LEO Pharma Inc. | 50222-501 | 50222-501-51 | 40 CARTON in 1 CASE (50222-501-51) > 1 BOTTLE in 1 CARTON > 4 g in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;TOPICAL | Strength | 0.064%;0.005% | ||||
| Approval Date: | May 9, 2008 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 25, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jan 25, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jan 27, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PLAQUE PSORIASIS | ||||||||
Expired US Patents for NDA 022185
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | Start Trial | Start Trial |
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | Start Trial | Start Trial |
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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