Details for New Drug Application (NDA): 218613
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NDA 218613 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
Summary for 218613
| Tradename: | LOFEXIDINE HYDROCHLORIDE |
| Applicant: | Regcon Holdings |
| Ingredient: | lofexidine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218613
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 218613 | ANDA | Indoco Remedies Limited | 14445-146 | 14445-146-36 | 1 BOTTLE in 1 CARTON (14445-146-36) / 36 TABLET, COATED in 1 BOTTLE |
| LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 218613 | ANDA | Indoco Remedies Limited | 14445-146 | 14445-146-96 | 1 BOTTLE in 1 CARTON (14445-146-96) / 96 TABLET, COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.18MG BASE | ||||
| Approval Date: | Aug 20, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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