Application 090713
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | No | No |
| 002 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-4094 | Palonosetron Hydrochloride | Palonosetron Hydrochloride | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-4094 | Palonosetron Hydrochloride | Palonosetron Hydrochloride | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-4094 | Palonosetron Hydrochloride | Palonosetron Hydrochloride | Teva Parenteral Medicines, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9286 | ORIG | 2018-04-05 |