Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050341
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUNGIZONE AMPHOTERICIN B 100MG/ML SUSPENSION;ORAL Discontinued 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
06/02/1971 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/17/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/11/1996 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/07/1996 SUPPL-3 Labeling

Label is not available on this site.

07/24/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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