Details for New Drug Application (NDA): 204963
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The generic ingredient in DESIPRAMINE HYDROCHLORIDE is desipramine hydrochloride. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the desipramine hydrochloride profile page.
Summary for 204963
Tradename: | DESIPRAMINE HYDROCHLORIDE |
Applicant: | Novast Labs |
Ingredient: | desipramine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204963
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DESIPRAMINE HYDROCHLORIDE | desipramine hydrochloride | TABLET;ORAL | 204963 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-112 | 50742-112-01 | 100 TABLET in 1 BOTTLE (50742-112-01) |
DESIPRAMINE HYDROCHLORIDE | desipramine hydrochloride | TABLET;ORAL | 204963 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-113 | 50742-113-01 | 100 TABLET in 1 BOTTLE (50742-113-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 26, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 26, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Dec 26, 2017 | TE: | AB | RLD: | No |
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