Details for New Drug Application (NDA): 020329
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NDA 020329 describes GLUCOTROL XL, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. Additional details are available on the GLUCOTROL XL profile page.
The generic ingredient in GLUCOTROL XL is glipizide. There are eighteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the glipizide profile page.
The generic ingredient in GLUCOTROL XL is glipizide. There are eighteen drug master file entries for this compound. Forty-three 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: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Aug 10, 1999 | TE: | AB | 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 | 020329-002 | Apr 26, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-001 | Apr 26, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-001 | Apr 26, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-003 | Aug 10, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-002 | Apr 26, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-003 | Aug 10, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | GLUCOTROL XL | glipizide | TABLET, EXTENDED RELEASE;ORAL | 020329-003 | Aug 10, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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