Details for New Drug Application (NDA): 071422
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The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 071422
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Endo Operations |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 071422
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071422 | ANDA | medsource pharmaceuticals | 45865-968 | 45865-968-30 | 30 CAPSULE in 1 BOTTLE (45865-968-30) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071422 | ANDA | Par Pharmaceutical, Inc. | 49884-222 | 49884-222-01 | 100 CAPSULE in 1 BOTTLE (49884-222-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Nov 9, 1987 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Nov 9, 1987 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Nov 9, 1987 | TE: | RLD: | No |
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