Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201720
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 100MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/03/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/11/2025 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2025 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2025 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/25/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/14/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |