Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103362
Company: BERLEX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUKINE SARGRAMOSTIM 250UG/ML VIAL Prescription None No No
LEUKINE SARGRAMOSTIM 500UG/ML 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
03/05/1991 ORIG-1 Approval N/A; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2018 SUPPL-5240 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103362Orig1s5240ltr.pdf
02/10/2017 SUPPL-5237 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103362Orig1s5237ltr.pdf
11/04/2008 SUPPL-5140 Supplement

Label is not available on this site.

03/14/2002 SUPPL-5012 Supplement

Label is not available on this site.

11/24/1995 SUPPL-1048 Supplement

Label is not available on this site.

12/22/1995 SUPPL-1045 Supplement

Label is not available on this site.

09/15/1995 SUPPL-1033 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2018 SUPPL-5240 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf
02/10/2017 SUPPL-5237 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf

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