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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085844
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE SULFAMETHOXAZOLE 500MG 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
03/23/1978 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
05/11/1984 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

05/11/1984 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

11/23/1983 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

11/23/1983 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

02/23/1983 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/23/1983 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/10/1982 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

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