Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050612
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;0.6% OINTMENT;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
12/01/1989 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
06/07/2018 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050612s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050612Orig1s021ltr.pdf
03/20/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050612s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050612Orig1s020ltr.pdf
10/22/2003 SUPPL-14 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50612SCM014ltr.pdf
01/28/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

10/02/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/09/1999 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/29/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/04/1997 SUPPL-6 Manufacturing (CMC)-Control

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-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050612s021lbl.pdf
03/20/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050612s020lbl.pdf

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