Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012157
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORFLEX | ORPHENADRINE CITRATE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
11/04/1959 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
---|---|---|---|---|---|
04/02/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012157s028ltr.pdf | |
09/12/1997 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/16/1996 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/11/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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07/26/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/1989 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/11/1995 | SUPPL-22 | Labeling |
Label is not available on this site. |
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08/26/1980 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/21/1980 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/03/1975 | SUPPL-12 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/02/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf |