ADAGEN از شرکت LEADIANT BIOSCI INC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ADAGEN از شرکت LEADIANT BIOSCI INC

Biologic License Application (BLA): 019818

Company: LEADIANT BIOSCI INC

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ADAGENPEGADEMASE BOVINE250 UNITS/MLINJECTABLE;INJECTIONDiscontinued

None

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
03/21/1990ORIG-1 Approval

N/A; Orphan

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
12/21/2015SUPPL-56 Supplement

Label is not available on this site.

07/17/2014SUPPL-55 Supplement

Label is not available on this site.

06/05/2014SUPPL-53 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019818Orig1s053ltr.pdf

03/04/2014SUPPL-52 Supplement

Label is not available on this site.

12/17/2013SUPPL-51 Supplement

Label is not available on this site.

01/10/2014SUPPL-50 Supplement

Label is not available on this site.

10/15/2013SUPPL-48 Supplement

Label is not available on this site.

10/07/2013SUPPL-47 Supplement

Label is not available on this site.

01/15/2013SUPPL-46 Supplement

Label is not available on this site.

09/25/2008SUPPL-42 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019818s042ltr.pdf

10/26/2007SUPPL-34 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019818s034ltr.pdf

04/15/2002SUPPL-24 Supplement

Label is not available on this site.

08/17/2001SUPPL-23 Supplement

Label is not available on this site.

09/16/1998SUPPL-17 Supplement

Label is not available on this site.

12/06/1993SUPPL-14 Supplement

Label is not available on this site.

06/16/1994SUPPL-13 Supplement

Label is not available on this site.

08/11/1993SUPPL-11 Supplement

Label is not available on this site.

11/10/1992SUPPL-9 Supplement

Label is not available on this site.

12/28/1992SUPPL-8 Supplement

Label is not available on this site.

03/09/1993SUPPL-7 Supplement

Label is not available on this site.

04/22/1992SUPPL-5 Supplement

Label is not available on this site.

04/13/1992SUPPL-4 Supplement

Label is not available on this site.

09/27/1991SUPPL-3 Supplement

Label is not available on this site.

06/10/1991SUPPL-2 Supplement

Label is not available on this site.

11/28/1990SUPPL-1 Supplement

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
06/05/2014SUPPL-53

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf
09/25/2008SUPPL-42

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf
10/26/2007SUPPL-34

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf
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