Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078392
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG 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 |
---|---|---|---|---|---|---|---|
12/31/2007 | 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 |
---|---|---|---|---|---|
09/18/2014 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf | |
05/30/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
05/30/2013 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/13/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/078392s011lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/18/2014 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf | |
04/13/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/078392s011lbl.pdf |
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078262 | AMNEAL |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078863 | BIONPHARMA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078392 | DR REDDYS |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078522 | FRESENIUS KABI USA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077913 | HIKMA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091136 | MYLAN ASI |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078534 | SANDOZ |