Details for New Drug Application (NDA): 020682
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The generic ingredient in GLYSET 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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 18, 1996 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 18, 1996 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 18, 1996 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020682
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | GLYSET | miglitol | TABLET;ORAL | 020682-001 | Dec 18, 1996 | ⤷ Get Started Free | ⤷ Get Started Free |
| Pfizer | GLYSET | miglitol | TABLET;ORAL | 020682-003 | Dec 18, 1996 | ⤷ Get Started Free | ⤷ Get Started Free |
| Pfizer | GLYSET | miglitol | TABLET;ORAL | 020682-002 | Dec 18, 1996 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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