Application 075360
- Type
- ANDA
- Sponsor
- GRANULES INDIA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 100MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 300MG | No | No |
| 003 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-5631 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-5632 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-5633 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 10544-436 | Gabapentin | Gabapentin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-447 | Gabapentin | Gabapentin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-055 | Gabapentin | Gabapentin | Rebel Distributors Corp. | ANDA | Current |
| 21695-056 | Gabapentin | Gabapentin | Rebel Distributors Corp. | ANDA | Current |
| 21695-344 | Gabapentin | Gabapentin | Rebel Distributors Corp. | ANDA | Current |
| 50090-1681 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-2590 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-2794 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 55154-1379 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55700-299 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 62207-922 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-922 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-923 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-923 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-924 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-924 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-926 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-926 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-927 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-927 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-928 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-928 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 63629-6983 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6983 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 68151-1028 | Gabapentin | Gabapentin | Carilion Materials Management | ANDA | Current |
| 68788-8176 | GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70010-108 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-108 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-109 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-109 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-118 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-118 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-926 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-926 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-927 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-927 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-928 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-928 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 71205-619 | GABAPENTIN | GABAPENTIN | Proficient Rx LP | ANDA | Current |
| 71205-661 | GABAPENTIN | GABAPENTIN | Proficient Rx LP | ANDA | Current |
| 71335-1997 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 71335-1997 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 71335-2004 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 71335-2004 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 80425-0150 | Neurontin | Gabapentin 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Neurontin | Gabapentin 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42984 | ORIG | 2007-07-06 |