Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050475
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET;ORAL | Prescription | AB | Yes | No |
| GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/19/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf | |
| 10/19/2010 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf | |
| 01/24/2007 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050475s053lbl.pdf | |
| 03/26/2003 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-peg_lbl.pdf |