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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017469
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNIPRED PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription AB 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
07/10/1973 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
12/18/2024 SUPPL-54 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017469Orig1s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017469Orig1s054ltr.pdf
03/04/2022 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017469Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017469Orig1s047ltr.pdf
10/11/2007 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017469s040ltr.pdf
05/15/2006 SUPPL-38 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf
05/15/2006 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017469s035LTR.pdf
04/17/2003 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17468slr019,17469slr031ltr.pdf
12/11/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
05/16/2000 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
08/17/1999 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
04/05/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
03/09/1999 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
10/06/1998 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/04/1998 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
06/27/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
03/18/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
03/05/1996 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
11/01/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
08/29/1995 SUPPL-18 Efficacy-Accelerated Approval Confirmatory Study

Label is not available on this site.
11/01/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
06/13/1995 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/10/1991 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/22/1991 SUPPL-14 Labeling

Label is not available on this site.
03/02/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
03/12/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
03/06/1989 SUPPL-11 Labeling

Label is not available on this site.
05/25/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
05/24/1979 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/24/1977 SUPPL-7 Labeling

Label is not available on this site.
04/06/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
04/06/1977 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
04/06/1977 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
04/06/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
12/05/1974 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
12/18/2024 SUPPL-54 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017469Orig1s054lbl.pdf
12/18/2024 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017469Orig1s054lbl.pdf
03/04/2022 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017469Orig1s047lbl.pdf
10/11/2007 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017469s040lbl.pdf
05/15/2006 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf
05/15/2006 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017469s35s38lbl.pdf
04/17/2003 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf

OMNIPRED

SUSPENSION/DROPS;OPHTHALMIC; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMNIPRED PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription Yes AB 017469 SANDOZ
PRED FORTE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription Yes AB 017011 ABBVIE
PREDNISOLONE ACETATE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 218256 AMNEAL
PREDNISOLONE ACETATE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 216935 LUPIN
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