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Application 215710
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
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 |
|---|
| 70756-424 | Doxepin Hydrochloride | doxepin hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-425 | Doxepin Hydrochloride | doxepin hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-426 | Doxepin Hydrochloride | doxepin hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-427 | Doxepin Hydrochloride | doxepin hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-428 | Doxepin Hydrochloride | doxepin hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 81469-415 | Doxepin Hydrochloride | doxepin hydrochloride | First Nation Group, LLC | ANDA | Current |
| 81469-416 | Doxepin Hydrochloride | doxepin hydrochloride | First Nation Group, LLC | ANDA | Current |
| 81469-417 | Doxepin Hydrochloride | doxepin hydrochloride | First Nation Group, LLC | ANDA | Current |
| 81469-418 | Doxepin Hydrochloride | doxepin hydrochloride | First Nation Group, LLC | ANDA | Current |
| 81469-419 | Doxepin Hydrochloride | doxepin hydrochloride | First Nation Group, LLC | ANDA | Current |