Details for New Drug Application (NDA): 207482
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The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 207482
Tradename: | DOXEPIN HYDROCHLORIDE |
Applicant: | Amneal Pharms Co |
Ingredient: | doxepin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207482
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 207482 | ANDA | Major Pharmaceuticals | 0904-7052 | 0904-7052-61 | 100 BLISTER PACK in 1 CARTON (0904-7052-61) / 1 CAPSULE in 1 BLISTER PACK |
DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 207482 | ANDA | Major Pharmaceuticals | 0904-7053 | 0904-7053-61 | 100 BLISTER PACK in 1 CARTON (0904-7053-61) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jun 28, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Jun 28, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Jun 28, 2017 | TE: | AB | RLD: | No |
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