Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080248
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBALON NAPHAZOLINE HYDROCHLORIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None No No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
03/24/1972 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
11/15/2002 SUPPL-42 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/03/2002 SUPPL-40 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/15/2001 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

08/15/2001 SUPPL-38 Manufacturing (CMC)-Facility

Label is not available on this site.

12/08/2000 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.

08/24/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/18/1999 SUPPL-35 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/29/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/29/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/21/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/21/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/27/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/07/1992 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/25/1991 SUPPL-28 Labeling

Label is not available on this site.

01/20/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/05/1987 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/12/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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