Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021665
Company: AMPHASTAR PHARM
Company: AMPHASTAR PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPHADASE | HYALURONIDASE | 150 UNITS/ML | INJECTABLE;INJECTION | Prescription | 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 |
---|---|---|---|---|---|---|---|
10/26/2004 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21665ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-665_Amphadase.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/28/2024 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021665s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021665Orig1s007ltr.pdf | |
06/19/2015 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
06/28/2012 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021665s005ltr.pdf | |
11/03/2005 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf | |
11/03/2005 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/28/2024 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021665s007lbl.pdf | |
08/28/2024 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021665s007lbl.pdf | |
06/28/2012 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf | |
11/03/2005 | SUPPL-2 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf |
11/03/2005 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf | |
10/26/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf |