Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076230
Company: PRINSTON INC
Company: PRINSTON INC
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 |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/20/2020 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
10/20/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/13/2003 | SUPPL-2 | 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 |