Details for New Drug Application (NDA): 211603
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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 211603
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 211603
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 211603 | ANDA | Medsource Pharmaceuticals | 45865-103 | 45865-103-30 | 30 CAPSULE in 1 BOTTLE (45865-103-30) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 211603 | ANDA | Aurobindo Pharma Limited | 59651-173 | 59651-173-01 | 100 CAPSULE in 1 BOTTLE (59651-173-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 27, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Mar 27, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Mar 27, 2019 | TE: | AB | RLD: | No |
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