ANDA 80737, held by Am Regent. Cyanocobalamin.
As of Nov 15, 2026, ANDA 80737 (Cyanocobalamin), held by Am Regent, was first approved by FDA on Apr 26, 1972, with 21 approved supplements and 0 published complete response letters.
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see DRUG INTERACTIONS), use of a gluten-free diet in nontropical sprue, or a…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyanocobalamin1MG/ML · injectable;injection | Cyanocobalamin | RxReference drug |
| May 24, 2021 | Supplement 40Manufacturing | Approved | |
| Jun 27, 2002 | Supplement 23Manufacturing | Approved | None posted |
| Jun 27, 2002 | Supplement 22Manufacturing | Approved | None posted |
| May 14, 2001 | Supplement 21Labeling | Approved | None posted |
| May 14, 2001 | Supplement 20Manufacturing | Approved | None posted |
| Feb 21, 2001 | Supplement 19Manufacturing | Approved | None posted |
| Sep 11, 2000 | Supplement 17Manufacturing | Approved | None posted |
| Nov 19, 1999 | Supplement 18Manufacturing | Approved | None posted |
| Oct 30, 1997 | Supplement 16Manufacturing | Approved | None posted |
| Sep 17, 1996 | Supplement 15Labeling | Approved | None posted |
| Sep 17, 1996 | Supplement 14Manufacturing | Approved | None posted |
| Feb 28, 1996 | Supplement 13Manufacturing | Approved | None posted |
| Jul 29, 1992 | Supplement 11Manufacturing | Approved | None posted |
| Jul 29, 1992 | Supplement 10Manufacturing | Approved | None posted |
| Nov 28, 1989 | Supplement 12Labeling | Approved | None posted |
| Oct 20, 1988 | Supplement 9Labeling | Approved | None posted |
| Oct 20, 1988 | Supplement 5Labeling | Approved | None posted |
| Jan 17, 1986 | Supplement 8Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 7Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Aug 16, 1982 | Supplement 3Manufacturing | Approved | None posted |
| Apr 26, 1972 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
