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Application 212624
- Type
- ANDA
- Sponsor
- AJANTA PHARMA 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 |
|---|
| 27241-167 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-167 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-167 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-168 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-168 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-168 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-169 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-169 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-169 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-170 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-170 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-170 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-171 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-171 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-171 | Doxepin hydrochloride | Doxepin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 70518-3490 | Doxepin hydrochloride | Doxepin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3490 | Doxepin hydrochloride | Doxepin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3494 | Doxepin hydrochloride | Doxepin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3496 | Doxepin hydrochloride | Doxepin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3594 | Doxepin hydrochloride | Doxepin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71205-695 | Doxepin hydrochloride | Doxepin hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-2092 | Doxepin hydrochloride | Doxepin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-2188 | Doxepin hydrochloride | Doxepin hydrochloride | Bryant Ranch Prepack | ANDA | Current |