Application 201191
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55390-370 | Topotecan Hydrochloride | Topotecan Hydrochloride | Bedford Laboratories | ANDA | Current |