Details for New Drug Application (NDA): 209785
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NDA 209785 describes DESIPRAMINE HYDROCHLORIDE, which is a drug marketed by Actavis Totowa, Alembic, Amneal Pharms Co, Ani Pharms, Chartwell Rx, Heritage, Novast Labs, and Usl Pharma, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the DESIPRAMINE HYDROCHLORIDE profile page.
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.
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 209785
| Tradename: | DESIPRAMINE HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | desipramine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209785
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | desipramine hydrochloride | TABLET;ORAL | 209785 | ANDA | Alembic Pharmaceuticals Limited | 46708-315 | 46708-315-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-315-30) |
| DESIPRAMINE HYDROCHLORIDE | desipramine hydrochloride | TABLET;ORAL | 209785 | ANDA | Alembic Pharmaceuticals Limited | 46708-315 | 46708-315-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-315-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 7, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jul 7, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 7, 2021 | TE: | AB | RLD: | No | ||||
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