Application 019909
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOVIRAX | ACYCLOVIR | SUSPENSION;ORAL | 200MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8712 | Acyclovir | Acyclovir | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8712 | Acyclovir | Acyclovir | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-9735 | Zovirax | Acyclovir | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-9735 | Zovirax | Acyclovir | Mylan Pharmaceuticals Inc. | NDA | Current |
| 40076-953 | ZOVIRAX | acyclovir | Prestium Pharma, Inc. | NDA | Current |
| 40085-842 | Acyclovir | Acyclovir | Renaissance Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |