Details for New Drug Application (NDA): 205205
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NDA 205205 describes DEXLANSOPRAZOLE, which is a drug marketed by Endo Operations, Mylan, and Twi Pharms, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the DEXLANSOPRAZOLE profile page.
The generic ingredient in DEXLANSOPRAZOLE is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
The generic ingredient in DEXLANSOPRAZOLE is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
Summary for 205205
| Tradename: | DEXLANSOPRAZOLE |
| Applicant: | Mylan |
| Ingredient: | dexlansoprazole |
| Patents: | 0 |
Pharmacology for NDA: 205205
| Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 205205
Suppliers and Packaging for NDA: 205205
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 205205 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2085 | 0378-2085-93 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93) |
| DEXLANSOPRAZOLE | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 205205 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2086 | 0378-2086-77 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2086-77) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 19, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Jan 19, 2024 | TE: | AB | RLD: | No | ||||
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