Application 206997
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-303 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-303 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-303 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-304 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-304 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-304 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-305 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-305 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 16729-305 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |