Application 202459
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
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 |
|---|---|---|---|---|---|
| 0378-8700 | Acyclovir | acyclovir | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8700 | Acyclovir | acyclovir | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-550 | Acyclovir | acyclovir | Mylan Institutional Inc. | ANDA | Current |
| 51079-550 | Acyclovir | acyclovir | Mylan Institutional Inc. | ANDA | Current |
| 51079-550 | Acyclovir | acyclovir | Mylan Institutional Inc. | ANDA | Current |
| 51079-550 | Acyclovir | acyclovir | Mylan Institutional Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32265 | ORIG | 2013-04-09 |