Application 091244
- Type
- ANDA
- Sponsor
- HIKMA FARMACEUTICA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 200MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9005 | Testosterone Cypionate | Testosterone Cypionate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9659 | Testosterone Cypionate | Testosterone Cypionate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9659 | Testosterone Cypionate | Testosterone Cypionate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9726 | Testosterone Cypionate | Testosterone Cypionate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9726 | Testosterone Cypionate | Testosterone Cypionate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0574-0827 | Testosterone Cypionate | Testosterone Cypionate | Padagis US LLC | ANDA | Current |
| 0574-0827 | Testosterone Cypionate | Testosterone Cypionate | Paddock Laboratories, LLC | ANDA | Current |
| 0574-0827 | Testosterone Cypionate | Testosterone Cypionate | Paddock Laboratories, LLC | ANDA | Current |
| 0591-4128 | Testosterone Cypionate | Testosterone Cypionate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-4128 | Testosterone Cypionate | Testosterone Cypionate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-4128 | Testosterone Cypionate | Testosterone Cypionate | Actavis Pharma, Inc. | ANDA | Current |
| 0591-4128 | Testosterone Cypionate | Testosterone Cypionate | Actavis Pharma, Inc. | ANDA | Current |
| 50090-0330 | Testosterone Cypionate | Testosterone Cypionate | A-S Medication Solutions | ANDA | Current |
| 50090-0330 | Testosterone Cypionate | Testosterone Cypionate | A-S Medication Solutions | ANDA | Current |
| 50090-4920 | Testosterone Cypionate | Testosterone Cypionate | A-S Medication Solutions | ANDA | Current |
| 50090-4921 | Testosterone Cypionate | Testosterone Cypionate | A-S Medication Solutions | ANDA | Current |
| 63187-647 | Testosterone Cypionate | Testosterone Cypionate | Proficient Rx LP | ANDA | Current |
| 63187-647 | Testosterone Cypionate | Testosterone Cypionate | Proficient Rx LP | ANDA | Current |
| 63629-8705 | Testosterone Cypionate | Testosterone Cypionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8705 | Testosterone Cypionate | Testosterone Cypionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8705 | Testosterone Cypionate | Testosterone Cypionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8705 | Testosterone Cypionate | Testosterone Cypionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8706 | Testosterone Cypionate | Testosterone Cypionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8706 | Testosterone Cypionate | Testosterone Cypionate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8706 | Testosterone Cypionate | Testosterone Cypionate | Bryant Ranch Prepack | ANDA | Current |
| 69097-802 | Testosterone Cypionate | Testosterone Cypionate | Cipla USA Inc. | ANDA | Current |
| 69097-802 | Testosterone Cypionate | Testosterone Cypionate | Cipla USA Inc. | ANDA | Current |
| 71205-289 | Testosterone Cypionate | Testosterone Cypionate | Proficient Rx LP | ANDA | Current |
| 71205-289 | Testosterone Cypionate | Testosterone Cypionate | Proficient Rx LP | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53974 | ORIG | 2018-05-01 |
| 43246 | ORIG | 2013-01-22 |