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Application 017783
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 5MG | Yes | No |
| 002 | GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 10MG | Yes | Yes |
| 003 | GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 2.5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0049-4110 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4110 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4110 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4120 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4120 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4120 | Glucotrol | glipizide | Roerig | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 45098 | SUPPL | 2016-08-22 |
| 45144 | SUPPL | 2016-08-18 |
| 33347 | SUPPL | 2013-10-22 |
| 702 | SUPPL | 2013-10-16 |
| 701 | SUPPL | 2011-02-09 |
| 33346 | SUPPL | 2011-02-07 |
| 700 | SUPPL | 2009-11-19 |
| 11062 | SUPPL | 2009-09-17 |
| 33345 | SUPPL | 2008-11-07 |
| 13901 | SUPPL | 2008-10-29 |