Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020587
Company: LYMOL MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SCLEROSOL TALC 4GM/SPRAY AEROSOL;INTRAPLEURAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/24/1997 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020587_sclerosol_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2012 SUPPL-6 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020587s006lbl.pdf
02/23/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/23/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/02/2000 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/18/2012 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020587s006lbl.pdf

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