Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007959
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TENSILON | EDROPHONIUM CHLORIDE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
TENSILON PRESERVATIVE FREE | EDROPHONIUM CHLORIDE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
05/03/1951 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/26/2003 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf |
10/01/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/24/2002 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf |
08/09/1993 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/03/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/07/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |