Application 020629
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DENAVIR | PENCICLOVIR | CREAM;TOPICAL | 1% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0896 | Penciclovir | penciclovir | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-9720 | Denavir | penciclovir | Mylan Pharmaceuticals Inc. | NDA | Current |
| 40076-624 | Denavir | penciclovir | Prestium Pharma, Inc. | NDA | Current |
| 40076-624 | Denavir | penciclovir | Prestium Pharma, Inc. | NDA | Current |
| 40085-415 | Penciclovir | penciclovir | Renaissance Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |