Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021751
Company: HAMELN PHARMA PLUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTETATE ZINC TRISODIUM PENTETATE ZINC TRISODIUM EQ 1GM BASE/5ML (EQ 200MG BASE/ML) SOLUTION;INHALATION, INTRAVENOUS 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
08/11/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021751lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21749,21751ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-751_21-749_Pentetate.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/21/2013 SUPPL-8 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021751s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021751Orig1s008ltr.pdf
08/04/2005 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021749s002,021751s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2013 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021751s008lbl.pdf
08/11/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021751lbl.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