Application 213444
- Type
- ANDA
- Sponsor
- NOVAST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | No | No |
| 002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | No | No |
| 003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1.5MG | No | No |
| 004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2.25MG | No | No |
| 005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 3MG | No | No |
| 006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 3.75MG | No | No |
| 007 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 4.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50742-331 | Pramipexole dihydrochloride | Pramipexole dihydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-332 | Pramipexole dihydrochloride | Pramipexole dihydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-333 | Pramipexole dihydrochloride | Pramipexole dihydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-334 | Pramipexole dihydrochloride | Pramipexole dihydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-335 | Pramipexole dihydrochloride | Pramipexole dihydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-336 | Pramipexole dihydrochloride | Pramipexole dihydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-337 | Pramipexole dihydrochloride | Pramipexole dihydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |