Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076607
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/15/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076607ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/25/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/09/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/09/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/14/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |