Details for New Drug Application (NDA): 217975
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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 217975
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Unique Pharm |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 217975
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 217975 | ANDA | Rising Pharma Holdings, Inc. | 64980-594 | 64980-594-01 | 100 CAPSULE in 1 BOTTLE (64980-594-01) |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 217975 | ANDA | Rising Pharma Holdings, Inc. | 64980-595 | 64980-595-01 | 100 CAPSULE in 1 BOTTLE (64980-595-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No |
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