Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017441
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INFED IRON DEXTRAN EQ 50MG IRON/ML INJECTABLE;INJECTION Prescription BP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/29/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/12/2009 SUPPL-171 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017441s171lbl.pdf
11/26/2002 SUPPL-164 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2001 SUPPL-162 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2001 SUPPL-161 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17441S161ltr.pdf
07/24/2001 SUPPL-160 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/2001 SUPPL-159 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1999 SUPPL-158 Manufacturing (CMC)

Label is not available on this site.

04/15/1999 SUPPL-157 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1999 SUPPL-155 Manufacturing (CMC)

Label is not available on this site.

01/13/1999 SUPPL-154 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1998 SUPPL-153 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1997 SUPPL-152 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1997 SUPPL-151 Labeling

Label is not available on this site.

04/04/1997 SUPPL-150 Labeling

Label is not available on this site.

08/11/1995 SUPPL-149 Manufacturing (CMC)

Label is not available on this site.

04/13/1994 SUPPL-148 Labeling

Label is not available on this site.

04/12/1994 SUPPL-146 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/22/1992 SUPPL-145 Manufacturing (CMC)

Label is not available on this site.

08/05/1991 SUPPL-144 Labeling

Label is not available on this site.

07/12/1991 SUPPL-143 Labeling

Label is not available on this site.

07/12/1991 SUPPL-142 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1991 SUPPL-141 Manufacturing (CMC)

Label is not available on this site.

01/12/1988 SUPPL-139 Labeling

Label is not available on this site.

04/07/1986 SUPPL-138 Manufacturing (CMC)

Label is not available on this site.

05/13/1985 SUPPL-137 Labeling

Label is not available on this site.

06/17/1981 SUPPL-135 Labeling

Label is not available on this site.

06/15/1981 SUPPL-134 Labeling

Label is not available on this site.

06/15/1981 SUPPL-133 Labeling

Label is not available on this site.

06/15/1981 SUPPL-132 Labeling

Label is not available on this site.

02/18/1981 SUPPL-131 Labeling

Label is not available on this site.

03/05/1981 SUPPL-130 Labeling

Label is not available on this site.

03/05/1981 SUPPL-129 Labeling

Label is not available on this site.

02/03/1981 SUPPL-128 Labeling

Label is not available on this site.

01/16/1981 SUPPL-127 Labeling

Label is not available on this site.

08/20/1980 SUPPL-126 Labeling

Label is not available on this site.

08/20/1980 SUPPL-125 Labeling

Label is not available on this site.

07/07/1980 SUPPL-121 Labeling

Label is not available on this site.

04/01/1980 SUPPL-120 Labeling

Label is not available on this site.

01/21/1980 SUPPL-119 Labeling

Label is not available on this site.

01/21/1980 SUPPL-118 Labeling

Label is not available on this site.

01/21/1980 SUPPL-117 Labeling

Label is not available on this site.

01/21/1980 SUPPL-116 Labeling

Label is not available on this site.

01/21/1980 SUPPL-115 Labeling

Label is not available on this site.

01/21/1980 SUPPL-114 Labeling

Label is not available on this site.

01/21/1980 SUPPL-113 Labeling

Label is not available on this site.

08/13/1979 SUPPL-111 Labeling

Label is not available on this site.

08/13/1979 SUPPL-110 Labeling

Label is not available on this site.

08/13/1979 SUPPL-109 Labeling

Label is not available on this site.

08/13/1979 SUPPL-108 Labeling

Label is not available on this site.

08/13/1979 SUPPL-107 Labeling

Label is not available on this site.

08/13/1979 SUPPL-106 Labeling

Label is not available on this site.

08/13/1979 SUPPL-105 Labeling

Label is not available on this site.

08/07/1978 SUPPL-104 Labeling

Label is not available on this site.

07/31/1978 SUPPL-103 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-102 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-101 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-97 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-96 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-95 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-94 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-93 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-92 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-60 Labeling

Label is not available on this site.

07/31/1978 SUPPL-59 Labeling

Label is not available on this site.

07/31/1978 SUPPL-58 Labeling

Label is not available on this site.

07/31/1978 SUPPL-57 Labeling

Label is not available on this site.

07/31/1978 SUPPL-56 Labeling

Label is not available on this site.

10/04/1976 SUPPL-54 Labeling

Label is not available on this site.

10/04/1976 SUPPL-53 Labeling

Label is not available on this site.

10/04/1976 SUPPL-52 Labeling

Label is not available on this site.

10/04/1976 SUPPL-51 Labeling

Label is not available on this site.

10/04/1976 SUPPL-50 Labeling

Label is not available on this site.

10/04/1976 SUPPL-48 Labeling

Label is not available on this site.

10/04/1976 SUPPL-47 Labeling

Label is not available on this site.

10/04/1976 SUPPL-46 Labeling

Label is not available on this site.

01/22/1976 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1976 SUPPL-43 Labeling

Label is not available on this site.

10/04/1976 SUPPL-42 Labeling

Label is not available on this site.

10/04/1976 SUPPL-41 Labeling

Label is not available on this site.

10/04/1976 SUPPL-40 Labeling

Label is not available on this site.

10/04/1976 SUPPL-39 Labeling

Label is not available on this site.

10/04/1976 SUPPL-38 Labeling

Label is not available on this site.

10/04/1976 SUPPL-37 Labeling

Label is not available on this site.

10/04/1976 SUPPL-36 Labeling

Label is not available on this site.

10/04/1976 SUPPL-35 Labeling

Label is not available on this site.

10/04/1976 SUPPL-34 Labeling

Label is not available on this site.

10/04/1976 SUPPL-33 Labeling

Label is not available on this site.

10/04/1976 SUPPL-32 Labeling

Label is not available on this site.

10/04/1976 SUPPL-31 Labeling

Label is not available on this site.

10/04/1976 SUPPL-30 Labeling

Label is not available on this site.

10/04/1976 SUPPL-29 Labeling

Label is not available on this site.

10/04/1976 SUPPL-28 Labeling

Label is not available on this site.

07/31/1978 SUPPL-27 Labeling

Label is not available on this site.

10/04/1976 SUPPL-26 Labeling

Label is not available on this site.

10/04/1976 SUPPL-25 Labeling

Label is not available on this site.

10/04/1976 SUPPL-23 Labeling

Label is not available on this site.

10/04/1976 SUPPL-22 Labeling

Label is not available on this site.

10/04/1976 SUPPL-21 Labeling

Label is not available on this site.

10/04/1976 SUPPL-20 Labeling

Label is not available on this site.

10/04/1976 SUPPL-19 Labeling

Label is not available on this site.

10/04/1976 SUPPL-18 Labeling

Label is not available on this site.

10/04/1976 SUPPL-17 Labeling

Label is not available on this site.

10/04/1976 SUPPL-16 Labeling

Label is not available on this site.

10/04/1976 SUPPL-15 Labeling

Label is not available on this site.

03/26/1975 SUPPL-13 Labeling

Label is not available on this site.

03/26/1975 SUPPL-12 Labeling

Label is not available on this site.

03/26/1975 SUPPL-11 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/12/2009 SUPPL-171 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017441s171lbl.pdf

INFED

There are no Therapeutic Equivalents.

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