Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084094
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION 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
03/15/1976 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
01/28/2005 SUPPL-15 Labeling

Label is not available on this site.

08/03/2001 SUPPL-14 Labeling

Label is not available on this site.

12/15/1999 SUPPL-13 Labeling

Label is not available on this site.

09/19/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/14/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/22/1993 SUPPL-8 Labeling

Label is not available on this site.

06/30/1989 SUPPL-7 Labeling

Label is not available on this site.

02/20/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/20/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/05/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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