Details for New Drug Application (NDA): 207589
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The generic ingredient in ENSTILAR is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 207589
Tradename: | ENSTILAR |
Applicant: | Leo Pharma As |
Ingredient: | betamethasone dipropionate; calcipotriene |
Patents: | 8 |
Pharmacology for NDA: 207589
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207589
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589 | NDA | LEO Pharma Inc. | 50222-302 | 50222-302-60 | 1 CAN in 1 CARTON (50222-302-60) / 60 g in 1 CAN |
ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589 | NDA | LEO Pharma Inc. | 50222-302 | 50222-302-66 | 2 CAN in 1 CARTON (50222-302-66) / 60 g in 1 CAN |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.064%;0.005% | ||||
Approval Date: | Oct 16, 2015 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 10, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER |
Expired US Patents for NDA 207589
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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