Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012429
Company: ASPEN GLOBAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOGUANINE THIOGUANINE 40MG TABLET;ORAL Prescription None 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
01/18/1966 ORIG-1 Approval Type 1 - New Molecular Entity 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
11/15/2004 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12429s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12429s022ltr.pdf
12/19/2003 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr021_tabloid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12429slr021ltr.pdf
06/30/2003 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr019_tabloid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12429slr019ltr.pdf
07/03/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/2001 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12429s17ltr.pdf
07/15/1991 SUPPL-15 Labeling

Label is not available on this site.

04/05/1990 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/1987 SUPPL-13 Labeling

Label is not available on this site.

09/22/1986 SUPPL-12 Labeling

Label is not available on this site.

07/18/1988 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/1985 SUPPL-10 Labeling

Label is not available on this site.

08/06/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1984 SUPPL-8 Labeling

Label is not available on this site.

08/24/1978 SUPPL-7 Labeling

Label is not available on this site.

02/11/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2004 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12429s022lbl.pdf
12/19/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr021_tabloid_lbl.pdf
06/30/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr019_tabloid_lbl.pdf

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