Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050616
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRADEX DEXAMETHASONE; TOBRAMYCIN 0.1%;0.3% 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
09/28/1988 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
07/15/2004 SUPPL-22 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf
07/15/2004 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf
03/18/2003 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf
12/11/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/2003 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf
03/18/2003 SUPPL-16 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf
09/28/1999 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/29/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-11 Labeling

Label is not available on this site.

11/29/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1996 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/50-616S009.pdf
03/18/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1994 SUPPL-7 Labeling

Label is not available on this site.

02/03/1992 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1992 SUPPL-5 Labeling

Label is not available on this site.

08/31/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/27/1989 SUPPL-1 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
07/15/2004 SUPPL-22 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf
07/15/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf
03/18/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf
03/18/2003 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf
03/18/2003 SUPPL-16 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf

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