Application 211619
- Type
- ANDA
- Sponsor
- LEADING PHARMA LLC
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 |
|---|
| 69315-158 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-158 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-158 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-158 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-159 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-159 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-159 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-159 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-160 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-160 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-160 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-160 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-161 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-161 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-161 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-161 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-162 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-162 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-162 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |
| 69315-162 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | ANDA | Current |