Details for New Drug Application (NDA): 202337
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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 202337
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Rk Pharma |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202337
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | TABLET;ORAL | 202337 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-758 | 10135-758-30 | 30 TABLET, FILM COATED in 1 BOTTLE (10135-758-30) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | TABLET;ORAL | 202337 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-764 | 10135-764-30 | 30 TABLET, FILM COATED in 1 BOTTLE (10135-764-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 3MG BASE | ||||
Approval Date: | Jan 20, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | Jan 20, 2016 | TE: | AB | RLD: | No |
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