Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017100
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRED MILD PREDNISOLONE ACETATE 0.12% SUSPENSION/DROPS;OPHTHALMIC Prescription None Yes 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
11/10/1972 ORIG-1 Approval Type 3 - New Dosage Form 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
06/06/2018 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017100s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017100Orig1s045ltr_Redacted.pdf
05/04/2017 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017100s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017100Orig1s044ltr.pdf
03/19/2003 SUPPL-40 Labeling

Label is not available on this site.

04/12/2002 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/19/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/08/1998 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1997 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1996 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1993 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/07/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/27/1989 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/08/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1987 SUPPL-22 Labeling

Label is not available on this site.

01/27/1988 SUPPL-21 Labeling

Label is not available on this site.

07/08/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/02/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/29/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/04/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1979 SUPPL-9 Labeling

Label is not available on this site.

02/23/1977 SUPPL-8 Labeling

Label is not available on this site.

02/23/1977 SUPPL-7 Labeling

Label is not available on this site.

02/23/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1977 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1977 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2018 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017100s045lbl.pdf
05/04/2017 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017100s044lbl.pdf

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