Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077186
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
06/30/2008 | 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-5 | Labeling-Package Insert |
Label is not available on this site. |
||
08/29/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION; 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 |
---|---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078258 | AMNEAL |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078880 | BIONPHARMA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077297 | DR REDDYS |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078090 | FRESENIUS KABI USA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077177 | HIKMA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077186 | HIKMA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078629 | HIKMA FARMACEUTICA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091137 | MYLAN ASI |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079078 | RISING PHARMA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078531 | SANDOZ |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078835 | SANDOZ INC |