Application 076541
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 15MG | No | No |
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 30MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 45MG | No | No |
| 004 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 7.5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8078 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8078 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 16714-706 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-706 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-706 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-707 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-707 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-707 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-708 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-708 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-708 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-709 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-709 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-709 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 42291-494 | Mirtazapine | Mirtazapine | AvKARE | ANDA | Current |
| 50090-5296 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 53808-0735 | Mirtazapine | MIRTAZAPINE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0736 | Mirtazapine | MIRTAZAPINE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0737 | Mirtazapine | MIRTAZAPINE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-2366 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2366 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2366 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2367 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2367 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2367 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2368 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2368 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2368 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 68071-1659 | Mirtazapine | Mirtazapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1716 | Mirtazapine | Mirtazapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-1583 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1583 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2582 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2582 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2582 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 71335-0286 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0286 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0286 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0441 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0441 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0441 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0532 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0532 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23831 | ORIG | 2005-08-01 |