Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 208181
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | AB | No | No |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 12MG | TABLET;ORAL | Prescription | AB | No | No |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 16MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/08/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TIAGABINE HYDROCHLORIDE
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABITRIL | TIAGABINE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 020646 | CEPHALON |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 208181 | AMNEAL PHARMS CO |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 077555 | SUN PHARM INDS |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 206857 | WILSHIRE PHARMS INC |
TABLET;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABITRIL | TIAGABINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 020646 | CEPHALON |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AB | 208181 | AMNEAL PHARMS CO |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AB | 077555 | SUN PHARM INDS |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AB | 206857 | WILSHIRE PHARMS INC |
TABLET;ORAL; 12MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABITRIL | TIAGABINE HYDROCHLORIDE | 12MG | TABLET;ORAL | Prescription | Yes | AB | 020646 | CEPHALON |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 12MG | TABLET;ORAL | Prescription | No | AB | 208181 | AMNEAL PHARMS CO |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 12MG | TABLET;ORAL | Prescription | No | AB | 206857 | WILSHIRE PHARMS INC |
TABLET;ORAL; 16MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABITRIL | TIAGABINE HYDROCHLORIDE | 16MG | TABLET;ORAL | Prescription | Yes | AB | 020646 | CEPHALON |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 16MG | TABLET;ORAL | Prescription | No | AB | 208181 | AMNEAL PHARMS CO |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 16MG | TABLET;ORAL | Prescription | No | AB | 206857 | WILSHIRE PHARMS INC |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English