Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070473
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORAZEPAM LORAZEPAM 1MG 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
12/10/1985 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
12/01/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-18 Labeling

Label is not available on this site.

04/03/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/25/1991 SUPPL-14 Bioequivalence

Label is not available on this site.

03/25/1991 SUPPL-13 Bioequivalence

Label is not available on this site.

04/01/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/04/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/27/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/23/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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