Details for New Drug Application (NDA): 020766
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NDA 020766 describes XENICAL, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from one supplier. Additional details are available on the XENICAL profile page.
The generic ingredient in XENICAL is orlistat. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the orlistat profile page.
The generic ingredient in XENICAL is orlistat. There is one drug master file entry 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 | |||||
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