Application 050475
- Type
- NDA
- Sponsor
- VALEANT PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | TABLET;ORAL | 125MG | Yes | No |
| 002 | GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | TABLET;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0884-0763 | Gris-PEG | griseofulvin | Pedinol Pharmacal, Inc. | NDA | Current |
| 0884-0773 | Gris-PEG | griseofulvin | Pedinol Pharmacal, Inc. | NDA | Current |
| 53808-0261 | Gris-PEG | GRISEOFULVIN | State of Florida DOH Central Pharmacy | NDA | Current |
| 68682-519 | Griseofulvin | Griseofulvin | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-520 | Griseofulvin | Griseofulvin | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83957 | SUPPL | 2025-10-28 |
| 83956 | SUPPL | 2025-10-28 |
| 7764 | SUPPL | 2016-04-22 |
| 17843 | SUPPL | 2016-04-20 |
| 30043 | SUPPL | 2010-10-25 |
| 17842 | SUPPL | 2010-10-19 |
| 38949 | SUPPL | 2007-02-02 |
| 7763 | SUPPL | 2007-02-02 |
| 30042 | SUPPL | 2003-04-14 |
| 17841 | SUPPL | 2003-03-28 |