Details for New Drug Application (NDA): 207482
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NDA 207482 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Adaptis, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Endo Operations, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, and Strides Pharma, and is included in seventy-seven NDAs. It is available from forty-eight suppliers. Additional details are available on the DOXEPIN HYDROCHLORIDE profile page.
The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 207482
| Tradename: | DOXEPIN HYDROCHLORIDE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | doxepin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207482
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 207482 | ANDA | Major Pharmaceuticals | 0904-7052 | 0904-7052-61 | 100 BLISTER PACK in 1 CARTON (0904-7052-61) / 1 CAPSULE in 1 BLISTER PACK |
| DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 207482 | ANDA | Major Pharmaceuticals | 0904-7053 | 0904-7053-61 | 100 BLISTER PACK in 1 CARTON (0904-7053-61) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jun 28, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Jun 28, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jun 28, 2017 | TE: | AB | RLD: | No | ||||
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