Details for New Drug Application (NDA): 020329
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The generic ingredient in GLUCOTROL XL is glipizide. There are eighteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the glipizide profile page.
Summary for 020329
| Tradename: | GLUCOTROL XL |
| Applicant: | Pfizer |
| Ingredient: | glipizide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020329
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329 | NDA | Roerig | 0049-0174 | 0049-0174-02 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-02) |
| GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329 | NDA | Roerig | 0049-0174 | 0049-0174-03 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 26, 1994 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 26, 1994 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Aug 10, 1999 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020329
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-001 | Apr 26, 1994 | 5,024,843 | ⤷ Get Started Free |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-002 | Apr 26, 1994 | 4,612,008 | ⤷ Get Started Free |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-002 | Apr 26, 1994 | 5,591,454 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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