Details for New Drug Application (NDA): 218613
✉ Email this page to a colleague
NDA 218613 describes LOFEXIDINE HYDROCHLORIDE, which is a drug marketed by Indoco and is included in one NDA. It is available from two suppliers. Additional details are available on the LOFEXIDINE HYDROCHLORIDE profile page.
The generic ingredient in LOFEXIDINE HYDROCHLORIDE is lofexidine hydrochloride. Four 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. Four suppliers are listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
Summary for 218613
| Tradename: | LOFEXIDINE HYDROCHLORIDE |
| Applicant: | Indoco |
| 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 | ||||||||
Complete Access Available with Subscription
