Application 018714
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BILTRICIDE | PRAZIQUANTEL | TABLET;ORAL | 600MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50419-747 | Biltricide | praziquantel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-747 | Biltricide | praziquantel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-747 | Biltricide | praziquantel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-747 | Biltricide | praziquantel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-747 | Biltricide | praziquantel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-747 | Biltricide | praziquantel | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 76413-146 | Biltricide | praziquantel | Central Texas Community Health Centers | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77090 | SUPPL | 2023-12-20 |
| 77089 | SUPPL | 2023-12-19 |
| 57333 | SUPPL | 2019-01-23 |
| 57154 | SUPPL | 2019-01-09 |
| 11294 | SUPPL | 2014-03-05 |
| 15113 | SUPPL | 2014-02-27 |
| 15112 | SUPPL | 2010-08-20 |
| 11293 | SUPPL | 2010-08-01 |
| 33571 | SUPPL | 2004-07-21 |
| 15111 | SUPPL | 2004-07-21 |
| 11292 | SUPPL | 2004-07-21 |
| 1045 | SUPPL | 2004-07-21 |