Application 071422
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
| 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 006 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6970 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6970 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6971 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6971 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6972 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6972 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 45865-968 | Doxepin Hydrochloride | Doxepin Hydrochloride | medsource pharmaceuticals | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 63629-2180 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2180 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2180 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2181 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2181 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2181 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2182 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2182 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2182 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7852 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0642 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |