Application 018604
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOVIRAX | ACYCLOVIR | OINTMENT;TOPICAL | 5% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0187-0993 | Zovirax | acyclovir | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-0993 | Zovirax | acyclovir | Bausch Health Americas, Inc. | NDA | Current |
| 0187-0993 | Zovirax | acyclovir | Bausch Health US, LLC | NDA | Current |
| 0187-0993 | Zovirax | acyclovir | Bausch Health US LLC | NDA | Current |
| 0591-1159 | Acyclovir | acyclovir | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0591-1159 | Acyclovir | acyclovir | ACTAVIS PHARMA, INC. | NDA AUTHORIZED GENERIC | Current |
| 0591-1159 | Acyclovir | acyclovir | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0591-1159 | Acyclovir | acyclovir | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |