Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050586
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRED-G GENTAMICIN SULFATE; PREDNISOLONE ACETATE EQ 0.3% BASE;1% 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
06/10/1988 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
06/07/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050586s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050586Orig1s032ltr.pdf
03/20/2017 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050586s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050586Orig1s031ltr.pdf
12/20/2005 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf
12/20/2005 SUPPL-25 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf
04/12/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/28/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/08/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1997 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1991 SUPPL-13 Labeling

Label is not available on this site.

03/07/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/31/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/21/1989 SUPPL-5 Efficacy-New Indication

Label is not available on this site.

07/29/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/29/1988 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/30/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050586s032lbl.pdf
03/20/2017 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050586s031lbl.pdf
12/20/2005 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf
12/20/2005 SUPPL-25 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf

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