Application 204605
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACYCLOVIR | ACYCLOVIR | OINTMENT;TOPICAL | 5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-668 | Acyclovir | Acyclovir | NorthStar Rx LLC | ANDA | Current |
| 16714-668 | Acyclovir | Acyclovir | NorthStar Rx LLC | ANDA | Current |
| 16714-668 | Acyclovir | Acyclovir | NorthStar Rx LLC | ANDA | Current |
| 65162-835 | Acyclovir | Acyclovir | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-835 | Acyclovir | Acyclovir | Amneal Pharmaceuticals of New York, LLC | ANDA | Current |
| 65162-835 | Acyclovir | Acyclovir | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-835 | Acyclovir | Acyclovir | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32571 | ORIG | 2014-06-23 |