Details for New Drug Application (NDA): 210140
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NDA 210140 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-six 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. Forty-eight 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. Forty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 210140
| Tradename: | DOXEPIN HYDROCHLORIDE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | doxepin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210140
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 210140 | ANDA | Zydus Lifesciences Limited | 70771-1390 | 70771-1390-1 | 100 CAPSULE in 1 BOTTLE (70771-1390-1) |
| DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 210140 | ANDA | Zydus Lifesciences Limited | 70771-1390 | 70771-1390-4 | 10 BLISTER PACK in 1 CARTON (70771-1390-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1390-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Mar 21, 2023 | TE: | AB | RLD: | No | ||||
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