Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020315
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ORLAAM LEVOMETHADYL ACETATE HYDROCHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CONCENTRATE;ORAL Discontinued None Yes No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.

03/01/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

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.

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.

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