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. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/20/2020 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 |
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