Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090648
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
06/15/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090648Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/11/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/18/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
08/18/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
06/30/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 |