Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020191
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOMIDE LODOXAMIDE TROMETHAMINE EQ 0.1% BASE SOLUTION/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
09/23/1993 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2003 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20191slr018_alomide_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20191slr018ltr.pdf
12/04/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1999 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/09/1997 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/17/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1995 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
06/26/2003 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20191slr018_alomide_lbl.pdf

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