Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010401
Company: FHTA
Company: FHTA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYSOLINE | PRIMIDONE | 250MG/5ML | SUSPENSION;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
07/05/1956 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
12/20/2000 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/010401s013lbl.pdf | |
04/10/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
04/13/1995 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/25/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/20/2000 | SUPPL-13 | Manufacturing (CMC)-Expiration Date | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/010401s013lbl.pdf |