Skip to contentApplication 206119
- Type
- ANDA
- Sponsor
- PAR PHARM INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 15MG | No | No |
| 002 | TOLVAPTAN | TOLVAPTAN | TABLET;ORAL | 30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49884-768 | Tolvaptan | Tolvaptan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-768 | Tolvaptan | Tolvaptan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-770 | Tolvaptan | Tolvaptan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-770 | Tolvaptan | Tolvaptan | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71707 | ORIG | 2022-08-04 |