Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078969
Company: NATCO PHARMA
Company: NATCO PHARMA
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 |
---|---|---|---|---|---|---|---|
06/22/2009 | 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 |
---|---|---|---|---|---|
08/22/2022 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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08/22/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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08/22/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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10/17/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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12/07/2011 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |