Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204406
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | No | No |
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
07/06/2017 | ORIG-1 | Approval |
Label is not available on this site. |
TOPOTECAN HYDROCHLORIDE
SOLUTION;INTRAVENOUS; EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204406 | ACCORD HLTHCARE |
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 200582 | HOSPIRA INC |