Application 078922
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZIDOVUDINE | ZIDOVUDINE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6106 | Zidovudine | zidovudine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 53808-0878 | Zidovudine | zidovudine | State of Florida DOH Central Pharmacy | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9198 | ORIG | 2008-02-19 |