Application 211603
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45865-103 | Doxepin Hydrochloride | Doxepin Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 55700-768 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-768 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-783 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-783 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-831 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 59651-173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-174 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-174 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-174 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-175 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-175 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-175 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-176 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-176 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-176 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-177 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-177 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-177 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 68071-5179 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5179 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5260 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5260 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7731 | Doxepin Hydrochloride | Doxepin Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7731 | Doxepin Hydrochloride | Doxepin Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2274 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2274 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2274 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2371 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2371 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2371 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2401 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2401 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2401 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2468 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2468 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2468 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2519 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2519 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71205-534 | Doxepin Hydrochloride | Doxepin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-610 | Doxepin Hydrochloride | Doxepin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-610 | Doxepin Hydrochloride | Doxepin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1450 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1450 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1665 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1665 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72789-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |