Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020682
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLYSET | MIGLITOL | 25MG | TABLET;ORAL | Discontinued | None | Yes | No |
| GLYSET | MIGLITOL | 50MG | TABLET;ORAL | Discontinued | None | Yes | No |
| GLYSET | MIGLITOL | 100MG | TABLET;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/17/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf | |
| 04/24/2009 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020682s008lbl.pdf |