Details for New Drug Application (NDA): 219917
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NDA 219917 describes LOFEXIDINE HYDROCHLORIDE, which is a drug marketed by MSN, Novitium Pharma, and Regcon Holdings, and is included in three NDAs. It is available from four suppliers. Additional details are available on the LOFEXIDINE HYDROCHLORIDE profile page.
The generic ingredient in LOFEXIDINE HYDROCHLORIDE is lofexidine hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
The generic ingredient in LOFEXIDINE HYDROCHLORIDE is lofexidine hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
Summary for 219917
| Tradename: | LOFEXIDINE HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | lofexidine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219917
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 219917 | ANDA | ANI Pharmaceuticals, Inc. | 70954-909 | 70954-909-10 | 36 TABLET in 1 BOTTLE (70954-909-10) |
| LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 219917 | ANDA | ANI Pharmaceuticals, Inc. | 70954-909 | 70954-909-20 | 96 TABLET in 1 BOTTLE (70954-909-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.18MG BASE | ||||
| Approval Date: | Oct 22, 2025 | TE: | AB | RLD: | No | ||||
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