Application 203023
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 180MG | No | No |
| 003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 240MG | No | No |
| 004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 005 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 360MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-6146 | Diltiazem hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 63304-718 | Diltiazem hydrochloride | Diltiazem hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-719 | Diltiazem hydrochloride | Diltiazem hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-720 | Diltiazem hydrochloride | Diltiazem hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-721 | Diltiazem hydrochloride | Diltiazem hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-722 | Diltiazem hydrochloride | Diltiazem hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |