Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040530
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | AO | 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 |
|---|---|---|---|---|---|---|---|
| 01/31/2005 | 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 |
|---|---|---|---|---|---|
| 07/11/2025 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2025 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2021 | SUPPL-26 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/25/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/25/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION; 200MG/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AO | 085635 | PFIZER |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 207742 | AM REGENT |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 210362 | CIPLA |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 211817 | EUGIA PHARMA |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 090387 | HIKMA |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 091244 | HIKMA FARMACEUTICA |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 040530 | PADAGIS US |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 206368 | WILSHIRE PHARMS INC |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 215351 | XIROMED |