Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203711
Company: QILU PHARM HAINAN
Company: QILU PHARM HAINAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/08/2014 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203711Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203711Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/28/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
09/01/2021 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/01/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/08/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203711Orig1s000lbl.pdf |
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206846 | ACCORD HLTHCARE |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076974 | FRESENIUS KABI USA |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079224 | GLAND PHARMA LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090648 | GLAND PHARMA LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076967 | HIKMA |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077365 | HIKMA |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076781 | HIKMA FARMACEUTICA |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077473 | HOSPIRA |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203711 | QILU PHARM HAINAN |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077430 | SANDOZ |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077577 | WOCKHARDT |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078287 | BAXTER HLTHCARE CORP |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076972 | FRESENIUS KABI USA |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202253 | FRESENIUS KABI USA |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077011 | HIKMA |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077541 | HIKMA |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077548 | HOSPIRA |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077551 | SANDOZ |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077716 | WOCKHARDT |