Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018155
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPTICROM CROMOLYN SODIUM 4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
10/03/1984 ORIG-1 Approval Type 3 - New Dosage Form 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
03/19/2003 SUPPL-28 Labeling

Label is not available on this site.

04/12/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/24/2001 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/13/2001 SUPPL-22 Labeling

Label is not available on this site.

10/02/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/03/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-18 Efficacy-New Dosing Regimen

Label is not available on this site.

07/22/1992 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/13/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/09/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/04/1989 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/23/1987 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1987 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/24/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/12/1987 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/02/1986 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/20/1986 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/28/1985 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/23/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/24/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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