Application 084217
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHLOROTHIAZIDE | CHLOROTHIAZIDE | TABLET;ORAL | 500MG | No | No |
| 002 | CHLOROTHIAZIDE | CHLOROTHIAZIDE | TABLET;ORAL | 250MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0150 | Chlorothiazide | chlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0150 | Chlorothiazide | chlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0162 | Chlorothiazide | chlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0162 | Chlorothiazide | chlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |