Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INFED | FERRIC OXYHYDROXIDE | EQ 100MG IRON/2ML (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 |
|---|---|---|---|---|---|
| 09/14/2021 | SUPPL-180 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017441Orig1s180ltr.pdf |
| 04/20/2021 | SUPPL-179 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017441s179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017441Orig1s179ltr.pdf | |
| 09/11/2020 | SUPPL-178 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017441s178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017441Orig1s178ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/20/2021 | SUPPL-179 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017441s179lbl.pdf | |
| 09/11/2020 | SUPPL-178 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017441s178lbl.pdf | |
| 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.