Details for New Drug Application (NDA): 201951
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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 201951
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Actavis Elizabeth |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 201951
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | TABLET;ORAL | 201951 | ANDA | Actavis Pharma, Inc. | 0228-3315 | 0228-3315-03 | 30 TABLET, FILM COATED in 1 BOTTLE (0228-3315-03) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | TABLET;ORAL | 201951 | ANDA | Actavis Pharma, Inc. | 0228-3316 | 0228-3316-03 | 30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 3MG BASE | ||||
Approval Date: | Jul 26, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | Jul 26, 2013 | TE: | AB | RLD: | No |
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