Details for New Drug Application (NDA): 208181
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NDA 208181 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 three 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.
Summary for 208181
| Tradename: | TIAGABINE HYDROCHLORIDE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | tiagabine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208181
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 208181
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 208181 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1104 | 69238-1104-3 | 30 TABLET in 1 BOTTLE (69238-1104-3) |
| TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 208181 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1105 | 69238-1105-3 | 30 TABLET in 1 BOTTLE (69238-1105-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 8, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Dec 8, 2017 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12MG | ||||
| Approval Date: | Dec 8, 2017 | TE: | RLD: | No | |||||
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