Details for New Drug Application (NDA): 209920
✉ Email this page to a colleague
NDA 209920 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 209920
| Tradename: | LUBIPROSTONE |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | lubiprostone |
| Patents: | 0 |
Pharmacology for NDA: 209920
| Mechanism of Action | Chloride Channel Activators |
Medical Subject Heading (MeSH) Categories for 209920
Suppliers and Packaging for NDA: 209920
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 209920 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3479 | 0480-3479-06 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-3479-06) |
| LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 209920 | ANDA | Teva Pharmaceuticals, Inc. | 0480-4138 | 0480-4138-06 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4138-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 8MCG | ||||
| Approval Date: | Jan 18, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 24MCG | ||||
| Approval Date: | Jan 18, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
