Application 076466
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METOLAZONE | METOLAZONE | TABLET;ORAL | 5MG | No | No |
| 002 | METOLAZONE | METOLAZONE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0185-0055 | Metolazone | Metolazone | Eon Labs, Inc. | ANDA | Current |
| 0185-0055 | Metolazone | Metolazone | Eon Labs, Inc. | ANDA | Current |
| 0185-5600 | Metolazone | Metolazone | Eon Labs, Inc. | ANDA | Current |
| 0185-5600 | Metolazone | Metolazone | Eon Labs, Inc. | ANDA | Current |
| 63629-7875 | Metolazone | Metolazone | Bryant Ranch Prepack | ANDA | Current |
| 63629-7875 | Metolazone | Metolazone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8733 | Metolazone | Metolazone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8733 | Metolazone | Metolazone | Bryant Ranch Prepack | ANDA | Current |
| 63739-404 | Metolazone | Metolazone | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-404 | Metolazone | Metolazone | McKesson Corporation | ANDA | Current |
| 71610-286 | Metolazone | Metolazone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43079 | ORIG | 2012-10-12 |