Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078843
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/27/2008 | 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-3 | Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
GRANISETRON HYDROCHLORIDE
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 078843 | APOTEX INC |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 078037 | CHARTWELL MOLECULAR |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 078846 | DR REDDYS LABS LTD |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 078969 | NATCO PHARMA |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 078678 | ORBION PHARMS |
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 090817 | TARO |