Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084472
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL 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
06/16/1976 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084472Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/16/1988 SUPPL-8 Labeling

Label is not available on this site.

10/30/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/12/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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