Details for New Drug Application (NDA): 214131
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NDA 214131 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 214131
| Tradename: | LUBIPROSTONE |
| Applicant: | Zydus Pharms |
| Ingredient: | lubiprostone |
| Patents: | 0 |
Pharmacology for NDA: 214131
| Mechanism of Action | Chloride Channel Activators |
Medical Subject Heading (MeSH) Categories for 214131
Suppliers and Packaging for NDA: 214131
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 214131 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1641 | 70710-1641-1 | 100 CAPSULE in 1 BOTTLE (70710-1641-1) |
| LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 214131 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1641 | 70710-1641-6 | 60 CAPSULE in 1 BOTTLE (70710-1641-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 8MCG | ||||
| Approval Date: | Mar 23, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 24MCG | ||||
| Approval Date: | Mar 23, 2023 | TE: | AB | RLD: | No | ||||
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