Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207742
Company: AM REGENT
Company: AM REGENT
| 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 |
|---|---|---|---|---|---|---|---|
| 06/16/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/04/2018 | SUPPL-1 | Labeling-Container/Carton Labels, 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 | 040615 | SANDOZ |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 201720 | SUN PHARM INDS LTD |
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 086030 | WATSON PHARMS INC |
| 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 |