Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060783
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Discontinued None No No
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG 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
07/17/1968 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
08/09/2014 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

02/05/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/30/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/11/1992 SUPPL-19 Labeling

Label is not available on this site.

01/31/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/25/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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