Details for New Drug Application (NDA): 203965
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NDA 203965 describes MIGLITOL, which is a drug marketed by Westminster Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the MIGLITOL profile page.
The generic ingredient in MIGLITOL is miglitol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the miglitol profile page.
The generic ingredient in MIGLITOL is miglitol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the miglitol profile page.
Summary for 203965
| Tradename: | MIGLITOL |
| Applicant: | Westminster Pharms |
| Ingredient: | miglitol |
| Patents: | 0 |
Pharmacology for NDA: 203965
| Mechanism of Action | alpha Glucosidase Inhibitors |
Suppliers and Packaging for NDA: 203965
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIGLITOL | miglitol | TABLET;ORAL | 203965 | ANDA | Westminster Pharmaceuticals, LLC | 69367-303 | 69367-303-01 | 100 TABLET, COATED in 1 BOTTLE (69367-303-01) |
| MIGLITOL | miglitol | TABLET;ORAL | 203965 | ANDA | Westminster Pharmaceuticals, LLC | 69367-304 | 69367-304-01 | 100 TABLET, COATED in 1 BOTTLE (69367-304-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 24, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 24, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 24, 2015 | TE: | AB | RLD: | No | ||||
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