Details for New Drug Application (NDA): 213796
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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 213796
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Edenbridge Pharms |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213796
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 213796 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-935 | 42799-935-01 | 100 CAPSULE in 1 BOTTLE (42799-935-01) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 213796 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-935 | 42799-935-02 | 500 CAPSULE in 1 BOTTLE (42799-935-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Apr 19, 2022 | TE: | AB | RLD: | No |
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