Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208209
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 40MG | 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 |
---|---|---|---|---|---|---|---|
04/27/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/03/2025 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/11/2024 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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06/07/2023 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
VILAZODONE HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VIIBRYD | VILAZODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 022567 | ABBVIE |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208209 | ACCORD HLTHCARE |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208202 | ALEMBIC |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208228 | APOTEX |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208200 | INVAGEN PHARMS |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208212 | TEVA PHARMS USA |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VIIBRYD | VILAZODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 022567 | ABBVIE |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208209 | ACCORD HLTHCARE |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208202 | ALEMBIC |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208228 | APOTEX |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208200 | INVAGEN PHARMS |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208212 | TEVA PHARMS USA |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VIIBRYD | VILAZODONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | Yes | AB | 022567 | ABBVIE |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208209 | ACCORD HLTHCARE |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208202 | ALEMBIC |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208228 | APOTEX |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208200 | INVAGEN PHARMS |
VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208212 | TEVA PHARMS USA |