Application 090515
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 250MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | No | No |
| 003 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 750MG | No | No |
| 004 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 1GM | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-7976 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7976 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7976 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7977 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7977 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7977 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7978 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7978 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7978 | Levetiracetam | Levetiracetam | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 16714-034 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-034 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-035 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-035 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-035 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-035 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-310 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-310 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-310 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-537 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 16714-537 | Levetiracetam | Levetiracetam | NorthStar RxLLC | ANDA | Current |
| 31722-536 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals | ANDA | Current |
| 31722-536 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-537 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-537 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals | ANDA | Current |
| 31722-538 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals | ANDA | Current |
| 31722-538 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-539 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals | ANDA | Current |
| 31722-539 | Levetiracetam | Levetiracetam | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1333 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-1333 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-1333 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-1333 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-1333 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-2875 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-2875 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-6086 | Levetiracetam | Levetiracetam | A-S Medication Solutions | ANDA | Current |
| 53808-0602 | Levetiracetam | Levetiracetam | State of Florida DOH Central Pharmacy | ANDA | Current |
| 63629-8315 | Levetiracetam | Levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 65977-5036 | Levetiracetam | Levetiracetam | Hetero Drugs Ltd., | ANDA | Current |
| 65977-5037 | Levetiracetam | Levetiracetam | Hetero Drugs Ltd., | ANDA | Current |
| 65977-5038 | Levetiracetam | Levetiracetam | Hetero Drugs Ltd., | ANDA | Current |
| 65977-5039 | Levetiracetam | Levetiracetam | Hetero Drugs Ltd., | ANDA | Current |
| 67046-421 | Levetiracetam | Levetiracetam | Contract Pharmacy Services-PA | ANDA | Current |
| 68788-7430 | Levetiracetam | Levetiracetam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7430 | Levetiracetam | Levetiracetam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7430 | Levetiracetam | Levetiracetam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7430 | Levetiracetam | Levetiracetam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7884 | Levetiracetam | Levetiracetam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7884 | Levetiracetam | Levetiracetam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0554 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0554 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0947 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0947 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0947 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0947 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0947 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0947 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0947 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1796 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1796 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1796 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1796 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1796 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1796 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1796 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1901 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1901 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1901 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1901 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1901 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-2230 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-2230 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-2230 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 71335-0694 | Levetiracetam | Levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0694 | Levetiracetam | Levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0702 | Levetiracetam | Levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0702 | Levetiracetam | Levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 72189-190 | LEVETIRACETAM | LEVETIRACETAM | DIRECT RX | ANDA | Current |
| 72189-190 | LEVETIRACETAM | LEVETIRACETAM | DIRECT RX | ANDA | Current |
| 72189-229 | LEVETIRACETAM | LEVETIRACETAM | DIRECT RX | ANDA | Current |