Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020315
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORLAAM | LEVOMETHADYL ACETATE HYDROCHLORIDE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/09/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/17/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/01/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/2001 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20315S6LTR.PDF |
| 07/02/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/08/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |