Details for New Drug Application (NDA): 209450
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NDA 209450 describes LUBIPROSTONE, which is a drug marketed by Amneal, Dr Reddys, Endo Operations, Teva Pharms Usa Inc, and Zydus Pharms, and is included in five NDAs. It is available from six suppliers. Additional details are available on the LUBIPROSTONE profile page.
The generic ingredient in LUBIPROSTONE 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.
The generic ingredient in LUBIPROSTONE 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 209450
| Tradename: | LUBIPROSTONE |
| Applicant: | Amneal |
| Ingredient: | lubiprostone |
| Patents: | 0 |
Pharmacology for NDA: 209450
| Mechanism of Action | Chloride Channel Activators |
Medical Subject Heading (MeSH) Categories for 209450
Suppliers and Packaging for NDA: 209450
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 209450 | ANDA | AvKARE | 42291-475 | 42291-475-60 | 60 CAPSULE in 1 BOTTLE (42291-475-60) |
| LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 209450 | ANDA | AvKARE | 42291-476 | 42291-476-60 | 60 CAPSULE in 1 BOTTLE (42291-476-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 8MCG | ||||
| Approval Date: | Nov 30, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 24MCG | ||||
| Approval Date: | Nov 30, 2021 | TE: | AB | RLD: | No | ||||
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