Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013055
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORFLEX | ORPHENADRINE CITRATE | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/02/1960 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
02/11/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013055s021ltr.pdf | |
06/04/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/06/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/22/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/03/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/22/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/29/1978 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/24/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/03/1975 | SUPPL-8 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/11/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf |