Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201533
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
04/21/2016 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201533s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201533Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/24/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
PALONOSETRON HYDROCHLORIDE
INJECTABLE;INTRAVENOUS; EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202951 | AVET LIFESCIENCES |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206916 | BAXTER HLTHCARE CORP |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209287 | CHARTWELL RX |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 201533 | DR REDDYS |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204702 | EUGIA PHARMA |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206801 | FRESENIUS KABI USA |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206802 | FRESENIUS KABI USA |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207005 | HOSPIRA |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206416 | MYLAN INSTITUTIONAL |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215861 | NANJING KING-FRIEND |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205648 | QILU PHARM HAINAN |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204289 | SAGENT PHARMS INC |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205870 | SAGENT PHARMS INC |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202521 | SANDOZ |
PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090713 | TEVA PHARMS USA |