Application 216521
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 90MG | No | No |
| 004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50228-481 | Diltiazem Hydrochloride | Diltiazem hydrochloride | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-482 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-483 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-484 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | ScieGen Pharmaceuticals, Inc | ANDA | Current |