Application 070076
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLDOPA | METHYLDOPA | TABLET;ORAL | 500MG | No | Yes |
| 002 | METHYLDOPA | METHYLDOPA | TABLET;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0421 | Methyldopa | methyldopa | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0611 | Methyldopa | methyldopa | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-200 | Methyldopa | methyldopa | Mylan Institutional Inc. | ANDA | Current |
| 51079-200 | Methyldopa | methyldopa | Mylan Institutional Inc. | ANDA | Current |
| 51079-201 | Methyldopa | methyldopa | Mylan Institutional Inc. | ANDA | Current |
| 51079-201 | Methyldopa | methyldopa | Mylan Institutional Inc. | ANDA | Current |