Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073229
Company: CATALENT
Company: CATALENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
10/29/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/26/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
12/26/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
08/05/2014 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
06/29/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/18/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
01/27/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/14/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/15/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/15/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
VALPROIC ACID
CAPSULE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 073484 | BIONPHARMA |
VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 073229 | CATALENT |
VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 091037 | SUN PHARM INDS LTD |