Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076007
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | AB | No | No |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | AB | No | No |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | 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 |
---|---|---|---|---|---|---|---|
07/01/2002 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76007ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/28/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
08/05/2013 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/05/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/05/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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08/05/2013 | SUPPL-12 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
09/02/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 12.5MG;10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 077606 | AUROBINDO |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 076674 | COREPHARMA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 204058 | INVAGEN PHARMS |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 077912 | LUPIN |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 076230 | PRINSTON INC |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 076262 | SANDOZ |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 076007 | SUN PHARM INDS LTD |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | No | AB | 076194 | WATSON LABS |
ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Prescription | Yes | AB | 019888 | ALMATICA |
TABLET;ORAL; 12.5MG;20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 077606 | AUROBINDO |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 076674 | COREPHARMA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 204058 | INVAGEN PHARMS |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 077912 | LUPIN |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 076230 | PRINSTON INC |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 076262 | SANDOZ |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 076007 | SUN PHARM INDS LTD |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 076194 | WATSON LABS |
ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 019888 | ALMATICA |
TABLET;ORAL; 25MG;20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 077606 | AUROBINDO |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 076674 | COREPHARMA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 204058 | INVAGEN PHARMS |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 077912 | LUPIN |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 076230 | PRINSTON INC |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 076262 | SANDOZ |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 076007 | SUN PHARM INDS LTD |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | No | AB | 076194 | WATSON LABS |
ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 019888 | ALMATICA |