Application 201533
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | No | No |
| 002 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-834 | Palonosetron | Palonosetron | NorthStar Rx LLC | ANDA | Current |
| 16714-834 | Palonosetron | Palonosetron | NorthStar Rx LLC | ANDA | Current |
| 16714-834 | Palonosetron | Palonosetron | NorthStar Rx LLC | ANDA | Current |
| 16714-834 | Palonosetron | Palonosetron | NorthStar Rx LLC | ANDA | Current |
| 16714-834 | Palonosetron | Palonosetron | NorthStar Rx LLC | ANDA | Current |
| 55111-694 | Palonosetron | Palonosetron | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-694 | Palonosetron | Palonosetron | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-694 | Palonosetron | Palonosetron | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 68001-355 | Palonosetron | Palonosetron | BluePoint Laboratories | ANDA | Current |
| 68001-355 | Palonosetron | Palonosetron | BluePoint Laboratories | ANDA | Current |
| 68001-355 | Palonosetron | Palonosetron | BluePoint Laboratories | ANDA | Current |
| 68001-355 | Palonosetron | Palonosetron | BluePoint Laboratories | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9909 | ORIG | 2016-04-22 |
| 32117 | ORIG | 2011-11-21 |