Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080961
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE 4MG TABLET;ORAL 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
12/20/1972 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
03/28/1996 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

02/21/1989 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

04/01/1988 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

04/01/1988 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

04/01/1988 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

09/27/1989 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

08/23/1984 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

08/23/1984 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

12/14/1983 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

07/12/1983 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

02/22/1983 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

07/06/1982 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

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