Details for New Drug Application (NDA): 070791
NDA 070791 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, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Ph Health, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Sun Pharma Canada, Actavis Elizabeth, Rk Pharma, and Strides Pharma Intl, and is included in seventy-nine NDAs. It is available from forty-nine suppliers. Additional details are available on the DOXEPIN HYDROCHLORIDE profile page.
The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There is one drug master file entry for this compound. Fifty-one 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 is one drug master file entry for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 070791
| Tradename: | DOXEPIN HYDROCHLORIDE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | doxepin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 070791
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070791 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1049 | 0378-1049-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-01) |
| DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070791 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1049 | 0378-1049-10 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | May 13, 1986 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | May 13, 1986 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | May 13, 1986 | TE: | AB | RLD: | No | ||||
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