Details for New Drug Application (NDA): 074721
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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 074721
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Lannett Co Inc |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074721
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CONCENTRATE;ORAL | 074721 | ANDA | Lannett Company, Inc. | 54838-512 | 54838-512-40 | 120 mL in 1 BOTTLE, PLASTIC (54838-512-40) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Dec 29, 1998 | TE: | RLD: | No |
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