Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208218
Company: PAR PHARM INC
Company: PAR PHARM INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
04/27/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208218Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/02/2020 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
04/17/2020 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
03/12/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
09/12/2019 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
03/12/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/30/2019 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
10/23/2017 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
03/12/2020 | SUPPL-1 | Labeling |
Label is not available on this site. |
VIGABATRIN
FOR SOLUTION;ORAL; 500MG/PACKET
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SABRIL | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | Yes | AA | 022006 | LUNDBECK PHARMS LLC |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 214425 | ACCORD HLTHCARE |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213375 | ALKEM LABS LTD |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 210155 | AMNEAL PHARMS |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213519 | ANNORA PHARMA |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 211481 | DR REDDYS LABS LTD |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213469 | GRANULES PHARMS |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 211592 | INVAGEN PHARMS |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 208218 | PAR PHARM INC |
VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 209824 | TEVA PHARMS USA |
VIGADRONE | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 210196 | AUCTA |
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