Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085635
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | 100MG/ML | INJECTABLE;INJECTION | Prescription | AO | Yes | Yes |
| DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | AO | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/28/2025 | SUPPL-28 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/085635s028lbl.pdf | |
| 08/01/2018 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf | |
| 08/01/2018 | SUPPL-40 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf | |
| 05/11/2015 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/085635s030lbl.pdf | |
| 06/19/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085635s029lbl.pdf |