Details for New Drug Application (NDA): 214816
✉ Email this page to a colleague
NDA 214816 describes TIAGABINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, MSN, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in four NDAs. It is available from four suppliers. Additional details are available on the TIAGABINE HYDROCHLORIDE profile page.
The generic ingredient in TIAGABINE HYDROCHLORIDE is tiagabine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.
The generic ingredient in TIAGABINE HYDROCHLORIDE is tiagabine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.
Summary for 214816
| Tradename: | TIAGABINE HYDROCHLORIDE |
| Applicant: | Msn |
| Ingredient: | tiagabine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 214816
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 214816
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 214816 | ANDA | Northstar Rx LLC | 16714-151 | 16714-151-01 | 30 TABLET in 1 BOTTLE (16714-151-01) |
| TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 214816 | ANDA | Northstar Rx LLC | 16714-152 | 16714-152-01 | 30 TABLET in 1 BOTTLE (16714-152-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Nov 16, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Nov 16, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12MG | ||||
| Approval Date: | Nov 16, 2021 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
