Application 075116
- Type
- ANDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
Product, Drug, Ingredient table| 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8127 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8127 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8128 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8128 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8129 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8129 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 33261-829 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-1576 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3062 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3062 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 63629-3564 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68071-4005 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4005 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4155 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4155 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4371 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4371 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4664 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4664 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68682-993 | Diltiazem Hydrochloride | Diltiazem hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-993 | Diltiazem Hydrochloride | Diltiazem hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-994 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-994 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-997 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-997 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-998 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-998 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 70518-2088 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0634 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0634 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0643 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0643 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0867 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0867 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1389 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30761 | ORIG | 1999-12-23 |