Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079070
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 4MG | TABLET;ORAL | Prescription | AB | No | No |
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 8MG | 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 |
---|---|---|---|---|---|---|---|
11/10/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079070s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/10/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
05/20/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/20/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/17/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
07/21/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
PERINDOPRIL ERBUMINE
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 2MG | TABLET;ORAL | Prescription | No | AB | 079070 | AUROBINDO PHARMA |
TABLET;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 4MG | TABLET;ORAL | Prescription | No | AB | 079070 | AUROBINDO PHARMA |
TABLET;ORAL; 8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 8MG | TABLET;ORAL | Prescription | No | AB | 079070 | AUROBINDO PHARMA |