Details for New Drug Application (NDA): 016987
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NDA 016987 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, Epic Pharma Llc, Ixora Lifescience, Jubilant Cadista, Lannett Co Inc, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Ph Health, Pts Consulting, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, and Strides Pharma Intl, and is included in seventy-eight NDAs. It is available from forty-seven 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 016987
| Tradename: | DOXEPIN HYDROCHLORIDE |
| Applicant: | New River |
| Ingredient: | doxepin hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 016987
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Expired US Patents for NDA 016987
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-001 | Approved Prior to Jan 1, 1982 | 3,420,851 | ⤷ Get Started Free |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-004 | Approved Prior to Jan 1, 1982 | 3,420,851 | ⤷ Get Started Free |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-006 | Approved Prior to Jan 1, 1982 | 3,420,851 | ⤷ Get Started Free |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-003 | Approved Prior to Jan 1, 1982 | 3,420,851 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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