Application 211285
- Type
- ANDA
- Sponsor
- EUGIA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROGESTERONE | PROGESTERONE | CAPSULE;ORAL | 100MG | No | No |
| 002 | PROGESTERONE | PROGESTERONE | CAPSULE;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5928 | Progesterone | Progesterone | A-S Medication Solutions | ANDA | Current |
| 59651-152 | Progesterone | Progesterone | Aurobindo Pharma Limited | ANDA | Current |
| 59651-152 | Progesterone | Progesterone | Aurobindo Pharma Limited | ANDA | Current |
| 59651-152 | Progesterone | Progesterone | Aurobindo Pharma Limited | ANDA | Current |
| 59651-153 | Progesterone | Progesterone | Aurobindo Pharma Limited | ANDA | Current |
| 59651-153 | Progesterone | Progesterone | Aurobindo Pharma Limited | ANDA | Current |
| 59651-153 | Progesterone | Progesterone | Aurobindo Pharma Limited | ANDA | Current |
| 60687-611 | Progesterone | Progesterone | American Health Packaging | ANDA | Current |
| 70518-2560 | Progesterone | Progesterone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2560 | Progesterone | Progesterone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2560 | Progesterone | Progesterone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2560 | Progesterone | Progesterone | REMEDYREPACK INC. | ANDA | Current |
| 70518-3392 | Progesterone | Progesterone | REMEDYREPACK INC. | ANDA | Current |
| 70934-535 | Progesterone | Progesterone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-1406 | Progesterone | Progesterone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1406 | Progesterone | Progesterone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1443 | Progesterone | Progesterone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1443 | Progesterone | Progesterone | Bryant Ranch Prepack | ANDA | Current |
| 72189-204 | PROGESTERONE | PROGESTERONE | direct rx | ANDA | Current |
| 72189-217 | PROGESTERONE | PROGESTERONE | direct rx | ANDA | Current |
| 72189-217 | PROGESTERONE | PROGESTERONE | direct rx | ANDA | Current |
| 76420-072 | Progesterone | Progesterone | Asclemed USA, Inc. | ANDA | Current |
| 76420-072 | Progesterone | Progesterone | Asclemed USA, Inc. | ANDA | Current |
| 76420-073 | Progesterone | Progesterone | Asclemed USA, Inc. | ANDA | Current |
| 76420-073 | Progesterone | Progesterone | Asclemed USA, Inc. | ANDA | Current |