Application 085635
- Type
- ANDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 50MG/ML | No | No |
| 002 | DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 100MG/ML | No | Yes |
| 003 | DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 200MG/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-0085 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0085 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0085 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0086 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0086 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0086 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0347 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0347 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0417 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0417 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0009-0520 | Depo-Testosterone | testosterone cypionate | Pharmacia and Upjohn Company LLC | ANDA | Current |
| 0409-6557 | Testosterone Cypionate | testosterone cypionate | Hospira, Inc. | ANDA | Current |
| 0409-6557 | Testosterone Cypionate | testosterone cypionate | Hospira, Inc. | ANDA | Current |
| 0409-6562 | Testosterone Cypionate | testosterone cypionate | Hospira, Inc. | ANDA | Current |
| 0409-6562 | Testosterone Cypionate | testosterone cypionate | Hospira, Inc. | ANDA | Current |
| 0409-6562 | Testosterone Cypionate | testosterone cypionate | Hospira, Inc. | ANDA | Current |
| 0409-6562 | Testosterone Cypionate | testosterone cypionate | Hospira, Inc. | ANDA | Current |
| 50090-0746 | Depo-Testosterone | testosterone cypionate | A-S Medication Solutions | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83094 | SUPPL | 2025-08-12 |
| 57501 | SUPPL | 2019-02-12 |
| 18508 | SUPPL | 2015-05-12 |
| 43197 | SUPPL | 2014-08-06 |
| 43196 | SUPPL | 2014-08-06 |
| 22668 | SUPPL | 2014-08-06 |
| 18507 | SUPPL | 2014-07-16 |