Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079245
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | AB | No | No |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/09/2009 | 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 |
---|---|---|---|---|---|
08/20/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
01/03/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 10MG;12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 079245 | AUROBINDO PHARMA |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 090228 | INVAGEN PHARMS |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076961 | SANDOZ |
TABLET;ORAL; 20MG;12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 079245 | AUROBINDO PHARMA |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 090228 | INVAGEN PHARMS |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076961 | SANDOZ |