Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091284
Company: SAGENT PHARMS
Company: SAGENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/26/2011 | ORIG-1 | Approval |
Label is not available on this site. |
TOPOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 4MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYCAMTIN | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020671 | NOVARTIS |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202351 | ACCORD HLTHCARE |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090620 | ACTAVIS TOTOWA |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091199 | CIPLA |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201191 | DR REDDYS LABS LTD |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091089 | FRESENIUS KABI USA |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201166 | MEITHEAL |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206962 | NOVAST LABS |
| TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091284 | SAGENT PHARMS |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English