Application 205771
- Type
- ANDA
- Sponsor
- HIKMA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9657 | Acyclovir | Acyclovir | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9657 | Acyclovir | Acyclovir | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9658 | Acyclovir | Acyclovir | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9658 | Acyclovir | Acyclovir | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10498 | ORIG | 2016-03-04 |