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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 050114
Company: ALLERQUEST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRE-PEN BENZYLPENICILLOYL POLYLYSINE 60UMOLAR INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/1974 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
09/18/2009 SUPPL-8 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050114s008ltr.pdf
04/06/2000 SUPPL-7 Supplement

Label is not available on this site.

03/30/1989 SUPPL-5 Supplement

Label is not available on this site.

12/02/1981 SUPPL-4 Supplement

Label is not available on this site.

11/28/1978 SUPPL-3 Supplement

Label is not available on this site.

02/09/1976 SUPPL-2 Supplement

Label is not available on this site.

10/30/1974 SUPPL-1 Supplement

Label is not available on this site.

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