Details for New Drug Application (NDA): 021908
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The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.
Summary for 021908
Tradename: | AMITIZA |
Applicant: | Sucampo Pharma Llc |
Ingredient: | lubiprostone |
Patents: | 5 |
Pharmacology for NDA: 021908
Mechanism of Action | Chloride Channel Activators |
Medical Subject Heading (MeSH) Categories for 021908
Suppliers and Packaging for NDA: 021908
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMITIZA | lubiprostone | CAPSULE;ORAL | 021908 | NDA AUTHORIZED GENERIC | Endo USA, Inc. | 0254-3028 | 0254-3028-02 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3028-02) |
AMITIZA | lubiprostone | CAPSULE;ORAL | 021908 | NDA AUTHORIZED GENERIC | Endo USA, Inc. | 0254-3029 | 0254-3029-02 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3029-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 24MCG | ||||
Approval Date: | Jan 31, 2006 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 25, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 1, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT |
Expired US Patents for NDA 021908
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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