Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016624
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HMS MEDRYSONE 1% SUSPENSION;OPHTHALMIC 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
11/28/1969 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/12/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

08/23/2002 SUPPL-41 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16624s41lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16624scm041ltr.pdf
04/12/2001 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/28/1998 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1996 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1993 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1989 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/30/1989 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1989 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/18/1986 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1982 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/17/1982 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/22/1980 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/02/1979 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1976 SUPPL-22 Labeling

Label is not available on this site.

10/27/1976 SUPPL-21 Labeling

Label is not available on this site.

10/27/1976 SUPPL-20 Labeling

Label is not available on this site.

12/11/1975 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1975 SUPPL-17 Labeling

Label is not available on this site.

05/27/1975 SUPPL-16 Labeling

Label is not available on this site.

10/27/1976 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1976 SUPPL-13 Labeling

Label is not available on this site.

11/25/1974 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1974 SUPPL-11 Labeling

Label is not available on this site.

06/26/1975 SUPPL-9

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/23/2002 SUPPL-41 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16624s41lbl.pdf

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