Details for New Drug Application (NDA): 020766
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The generic ingredient in XENICAL is orlistat. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the orlistat profile page.
Summary for 020766
Tradename: | XENICAL |
Applicant: | Cheplapharm |
Ingredient: | orlistat |
Patents: | 0 |
Pharmacology for NDA: 020766
Mechanism of Action | Lipase Inhibitors |
Suppliers and Packaging for NDA: 020766
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
XENICAL | orlistat | CAPSULE;ORAL | 020766 | NDA | H2-Pharma LLC | 61269-460 | 61269-460-90 | 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90) |
XENICAL | orlistat | CAPSULE;ORAL | 020766 | NDA AUTHORIZED GENERIC | H2-Pharma LLC | 61269-565 | 61269-565-90 | 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-565-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 120MG | ||||
Approval Date: | Apr 23, 1999 | TE: | RLD: | Yes |
Expired US Patents for NDA 020766
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | XENICAL | orlistat | CAPSULE;ORAL | 020766-001 | Apr 23, 1999 | 4,598,089*PED | ⤷ Subscribe |
Cheplapharm | XENICAL | orlistat | CAPSULE;ORAL | 020766-001 | Apr 23, 1999 | 6,004,996*PED | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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