Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020430
Company: ASPEN GLOBAL INC
Company: ASPEN GLOBAL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORGARAN | DANAPAROID SODIUM | 750 UNITS/0.6ML | 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 |
---|---|---|---|---|---|---|---|
12/24/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020430_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/26/2001 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-430S003_Orgaran_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20430s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-430S003_Orgaran.cfm | |
01/30/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
07/16/1997 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/26/2001 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-430S003_Orgaran_prntlbl.pdf |