Details for New Drug Application (NDA): 205437
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The generic ingredient in OTEZLA is apremilast. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.
Summary for 205437
Tradename: | OTEZLA |
Applicant: | Amgen Inc |
Ingredient: | apremilast |
Patents: | 3 |
Pharmacology for NDA: 205437
Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 205437
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OTEZLA | apremilast | TABLET;ORAL | 205437 | NDA | Amgen Inc | 55513-137 | 55513-137-60 | 60 TABLET, FILM COATED in 1 BOTTLE (55513-137-60) |
OTEZLA | apremilast | TABLET;ORAL | 205437 | NDA | Amgen Inc | 55513-137 | 55513-137-95 | 1 BLISTER PACK in 1 CARTON (55513-137-95) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 21, 2014 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Jul 20, 2026 | ||||||||
Regulatory Exclusivity Use: | CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS | ||||||||
Regulatory Exclusivity Expiration: | Apr 25, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Regulatory Exclusivity Expiration: | Jan 19, 2027 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY |
Expired US Patents for NDA 205437
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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