Skip to content
Application 210268
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
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 |
|---|
| 62135-560 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-561 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-562 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-563 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-564 | Doxepin Hydrochloride | Doxepin Hydrochloride | Chartwell RX, LLC | ANDA | Current |