Details for New Drug Application (NDA): 212997
✉ Email this page to a colleague
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 212997
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Lannett Co Inc |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 212997
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 212997 | ANDA | Lannett Company, Inc. | 0527-4062 | 0527-4062-37 | 100 CAPSULE in 1 BOTTLE (0527-4062-37) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 212997 | ANDA | Lannett Company, Inc. | 0527-4062 | 0527-4062-43 | 1000 CAPSULE in 1 BOTTLE (0527-4062-43) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jul 24, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Jul 24, 2020 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Jul 24, 2020 | TE: | RLD: | No |
Complete Access Available with Subscription