Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060429
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMYCIN TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Discontinued None No No
SUMYCIN TETRACYCLINE HYDROCHLORIDE 100MG CAPSULE;ORAL Discontinued None No No
SUMYCIN TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Discontinued None No No
SUMYCIN TETRACYCLINE HYDROCHLORIDE 125MG CAPSULE;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
09/17/1954 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
07/03/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/25/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/06/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/11/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/23/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/23/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/17/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/16/1997 SUPPL-9 Labeling

Label is not available on this site.

09/15/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/01/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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