Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018297
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPURIN ALLOPURINOL 100MG TABLET;ORAL Discontinued None No No
LOPURIN ALLOPURINOL 300MG 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
06/10/1980 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/18/1986 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1985 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/18/1985 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/1985 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/31/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1981 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/15/1985 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/10/1981 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/11/1982 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/11/1982 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/27/1981 SUPPL-1 Labeling

Label is not available on this site.

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