Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077561
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/02/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077561s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/19/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/19/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/19/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/11/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2016 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2015 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ZIPRASIDONE HYDROCHLORIDE
CAPSULE;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEODON | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020825 | VIATRIS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077561 | APOTEX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204117 | AUROBINDO PHARMA |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090348 | CHARTWELL RX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077565 | DR REDDYS LABS INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077560 | LUPIN PHARMS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204375 | MACLEODS PHARMS LTD |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077562 | SANDOZ INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208988 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEODON | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020825 | VIATRIS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077561 | APOTEX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204117 | AUROBINDO PHARMA |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090348 | CHARTWELL RX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077565 | DR REDDYS LABS INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077560 | LUPIN PHARMS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204375 | MACLEODS PHARMS LTD |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077562 | SANDOZ INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208988 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; EQ 60MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEODON | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020825 | VIATRIS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077561 | APOTEX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204117 | AUROBINDO PHARMA |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090348 | CHARTWELL RX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077565 | DR REDDYS LABS INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077560 | LUPIN PHARMS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204375 | MACLEODS PHARMS LTD |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077562 | SANDOZ INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208988 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; EQ 80MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEODON | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 020825 | VIATRIS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077561 | APOTEX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204117 | AUROBINDO PHARMA |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090348 | CHARTWELL RX |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077565 | DR REDDYS LABS INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077560 | LUPIN PHARMS |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204375 | MACLEODS PHARMS LTD |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077562 | SANDOZ INC |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208988 | ZYDUS LIFESCIENCES |