Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012813
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BLEPHAMIDE PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 0.2%;10% SUSPENSION;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
09/18/1961 ORIG-1 Approval Type 4 - New Combination 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
07/18/2017 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012813s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012813Orig1s062ltr.pdf
03/19/2003 SUPPL-57 Labeling

Label is not available on this site.

04/12/2002 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/26/2001 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

04/21/2000 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/2000 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1999 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1998 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1998 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1997 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1998 SUPPL-43 Labeling

Label is not available on this site.

12/02/1996 SUPPL-42 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/22/1994 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1993 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/06/1990 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/07/1989 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/14/1989 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1986 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/14/1986 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1986 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1986 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/23/1985 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1985 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/03/1998 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1981 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/15/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/15/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/08/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1978 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2017 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012813s062lbl.pdf

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