Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060593
Company: PURDUE GMP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEROMYCIN CYCLOSERINE 250MG CAPSULE;ORAL Prescription None No 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
06/29/1964 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
11/08/2018 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

11/08/2018 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

11/08/2018 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

11/08/2018 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

09/05/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2002 SUPPL-28 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/10/2001 SUPPL-27 Labeling

Label is not available on this site.

08/21/2001 SUPPL-26 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/04/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/02/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/30/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/26/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/23/1993 SUPPL-20 Bioequivalence

Label is not available on this site.

09/19/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/16/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

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