Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS INC
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/2008/077565s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/30/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
03/30/2023 | SUPPL-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/02/2021 | SUPPL-18 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
11/02/2021 | SUPPL-14 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
11/29/2019 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
11/29/2019 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/19/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
04/13/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/19/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
07/25/2013 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
03/22/2012 | SUPPL-1 | Labeling-Container/Carton Labels, 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 |