Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076139
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET;ORAL | Prescription | AB | No | No |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET;ORAL | Prescription | AB | No | No |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | 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 |
---|---|---|---|---|---|---|---|
11/25/2003 | 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 |
---|---|---|---|---|---|
09/29/2009 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
05/08/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
FOSINOPRIL SODIUM
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 076906 | APOTEX INC |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 091163 | AUROBINDO PHARMA LTD |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 076483 | CHARTWELL RX |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 077222 | INVAGEN PHARMS |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 205670 | PRINSTON INC |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 076139 | TEVA |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 076906 | APOTEX INC |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 091163 | AUROBINDO PHARMA LTD |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 076483 | CHARTWELL RX |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 077222 | INVAGEN PHARMS |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 205670 | PRINSTON INC |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 076139 | TEVA |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 076906 | APOTEX INC |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 091163 | AUROBINDO PHARMA LTD |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 076483 | CHARTWELL RX |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 077222 | INVAGEN PHARMS |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 205670 | PRINSTON INC |
FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 076139 | TEVA |