Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016635
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYANOCOBALAMIN CO 57 SCHILLING TEST KIT CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR 0.1MG;0.5uCi;60MG N/A;N/A 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
06/21/1968 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016635Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/31/1994 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1983 SUPPL-13 Labeling

Label is not available on this site.

11/21/1978 SUPPL-11 Labeling

Label is not available on this site.

07/27/1977 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/15/1977 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/24/1977 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

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