Details for New Drug Application (NDA): 202761
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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 202761
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202761
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | TABLET;ORAL | 202761 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-393 | 68382-393-01 | 100 TABLET in 1 BOTTLE (68382-393-01) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | TABLET;ORAL | 202761 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-393 | 68382-393-05 | 500 TABLET in 1 BOTTLE (68382-393-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 3MG BASE | ||||
Approval Date: | Aug 16, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | Aug 16, 2023 | TE: | RLD: | No |
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