Application 212285
- Type
- ANDA
- Sponsor
- UNIQUE PHARM LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | No | No |
| 002 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | No | No |
| 003 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-683 | Clomipramine Hydrochloride | Clomipramine Hydrochloride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-684 | Clomipramine Hydrochloride | Clomipramine Hydrochloride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-685 | Clomipramine Hydrochloride | Clomipramine Hydrochloride | Rising Pharma Holdings, Inc. | ANDA | Current |