Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084339
Company: FOSUN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYLBUTAZONE PHENYLBUTAZONE 100MG TABLET;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
01/10/1980 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
12/19/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/19/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/19/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/19/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/19/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/14/1984 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/10/1984 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/14/1984 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/23/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/22/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/26/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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