Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 101063
Company: MERCK
Company: MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELSPAR | ASPARAGINASE | 10,000IU/VIAL | VIAL | 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 |
---|---|---|---|---|---|---|---|
01/10/1978 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/16/2013 | SUPPL-5169 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/101063s5169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/101063Orig1s5169ltr.pdf | |
05/20/2010 | SUPPL-5121 | Supplement |
Label is not available on this site. |
||
03/30/2007 | SUPPL-5081 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/101063s5081LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/101063s5081LTR.pdf | |
07/21/2006 | SUPPL-5071 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/101063s5071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/101063 5071 Ltr.pdf | |
06/29/2004 | SUPPL-5036 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/101063_5036ltr.pdf |
08/01/2002 | SUPPL-5012 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/aspamer080102LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/aspamer080102L.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/16/2013 | SUPPL-5169 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/101063s5169lbl.pdf | |
03/30/2007 | SUPPL-5081 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/101063s5081LBL.pdf | |
07/21/2006 | SUPPL-5071 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/101063s5071lbl.pdf | |
08/01/2002 | SUPPL-5012 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/aspamer080102LB.pdf |