Application 213212
- Type
- ANDA
- Sponsor
- RISING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 12.5MG;200MG;50MG | No | No |
| 002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 18.75MG;200MG;75MG | No | No |
| 003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 25MG;200MG;100MG | No | No |
| 004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 31.25MG;200MG;125MG | No | No |
| 005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 37.5MG;200MG;150MG | No | No |
| 006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 50MG;200MG;200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-689 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA, LEVODOPA AND ENTACAPONE | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-690 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA, LEVODOPA AND ENTACAPONE | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-691 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA, LEVODOPA AND ENTACAPONE | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-692 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA, LEVODOPA AND ENTACAPONE | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-693 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA, LEVODOPA AND ENTACAPONE | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-694 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA, LEVODOPA AND ENTACAPONE | Rising Pharma Holdings, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70082 | ORIG | 2022-02-04 |