Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020484
Company: LEO PHARMA AS
Company: LEO PHARMA AS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INNOHEP | TINZAPARIN SODIUM | 20,000 IU/ML | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
07/14/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20484ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-484_Innohep.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2010 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020484s014ltr.pdf | |
12/23/2009 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020484s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020484s013ltr.pdf | |
12/29/2008 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020484s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020484s011ltr.pdf | |
11/07/2006 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020484s006LTR.pdf |
03/04/2003 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20484slr003ltr.pdf |
02/05/2002 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20484s2ltr.pdf |
11/21/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/07/2010 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf | |
12/23/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020484s013lbl.pdf | |
12/29/2008 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020484s011lbl.pdf | |
07/14/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf |