Application 213063
- Type
- ANDA
- Sponsor
- TARO PHARM INDS 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 |
|---|
| 16714-132 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | NORTHSTAR RX LLC | ANDA | Current |
| 16714-133 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | NORTHSTAR RX LLC | ANDA | Current |
| 16714-134 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | NORTHSTAR RX LLC | ANDA | Current |
| 16714-135 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | NORTHSTAR RX LLC | ANDA | Current |
| 16714-136 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | NORTHSTAR RX LLC | ANDA | Current |
| 50090-5286 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 51672-4217 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4218 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4219 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4220 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4221 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 55700-917 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-928 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 68071-2356 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-2949 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2949 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2949 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2984 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3017 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3017 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3020 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3020 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 71335-1704 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1704 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1770 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-2028 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 72189-161 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-355 | Doxepin HCL | Doxepin HCL | Direct_Rx | ANDA | Current |
| 72189-355 | Doxepin HCL | Doxepin HCL | Direct_Rx | ANDA | Current |