Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083590
Company: AKORN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPHAZOLINE HYDROCHLORIDE NAPHAZOLINE HYDROCHLORIDE 0.1% SOLUTION/DROPS;OPHTHALMIC Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/22/1974 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2012 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/30/2002 SUPPL-21 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/07/1999 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/25/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-11 Labeling

Label is not available on this site.

09/14/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/10/1991 SUPPL-8 Labeling

Label is not available on this site.

07/15/1991 SUPPL-7 Labeling

Label is not available on this site.

08/07/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/15/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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