Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021388
Company: LYMOL MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TALC TALC 5GM/BOT POWDER;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
12/15/2003 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21388_SterileTalclbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21388ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-388_SterileTalc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021388s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021388Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021388s002lbl.pdf
12/15/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21388_SterileTalclbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English