Details for New Drug Application (NDA): 215876
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NDA 215876 describes MEXILETINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Leading, Novast Labs, Rising, Senores Pharms, Teva, and Watson Labs, and is included in ten NDAs. It is available from fourteen suppliers. Additional details are available on the MEXILETINE HYDROCHLORIDE profile page.
The generic ingredient in MEXILETINE HYDROCHLORIDE is mexiletine hydrochloride. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mexiletine hydrochloride profile page.
The generic ingredient in MEXILETINE HYDROCHLORIDE is mexiletine hydrochloride. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mexiletine hydrochloride profile page.
Summary for 215876
| Tradename: | MEXILETINE HYDROCHLORIDE |
| Applicant: | Leading |
| Ingredient: | mexiletine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215876
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 215876 | ANDA | Leading Pharma, LLC | 69315-236 | 69315-236-01 | 100 CAPSULE in 1 BOTTLE (69315-236-01) |
| MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 215876 | ANDA | Leading Pharma, LLC | 69315-237 | 69315-237-01 | 100 CAPSULE in 1 BOTTLE (69315-237-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Feb 27, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 27, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Feb 27, 2023 | TE: | AB | RLD: | No | ||||
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