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Application 207174
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.002MG/ML (0.002MG/ML) | No | No |
| 002 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.005MG/ML (0.005MG/ML) | No | No |
| 003 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.01MG/2ML (0.005MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-310 | Paricalcitol | Paricalcitol | Accord Healthcare, Inc. | NDA | Current |
| 16729-310 | Paricalcitol | Paricalcitol | Accord Healthcare, Inc. | NDA | Current |
| 16729-310 | Paricalcitol | Paricalcitol | Accord Healthcare, Inc. | NDA | Current |
| 16729-311 | Paricalcitol | Paricalcitol | Accord Healthcare, Inc. | NDA | Current |
| 16729-311 | Paricalcitol | Paricalcitol | Accord Healthcare, Inc. | NDA | Current |
| 16729-311 | Paricalcitol | Paricalcitol | Accord Healthcare, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60589 | SUPPL | 2019-10-18 |
| 60586 | SUPPL | 2019-10-18 |
| 46033 | ORIG | 2016-12-06 |
| 46032 | ORIG | 2016-12-06 |
| 19961 | ORIG | 2016-03-04 |
| 32850 | ORIG | 2016-02-09 |