Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040084
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 750MG;7.5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 660MG;10MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;10MG 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
06/01/1995 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/040084.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2011 SUPPL-40 Labeling

Label is not available on this site.

12/24/2004 SUPPL-28 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
12/16/2004 SUPPL-26 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
12/16/2004 SUPPL-25 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
06/01/2004 SUPPL-24 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
11/13/2003 SUPPL-23 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/16/2003 SUPPL-22 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
04/25/2003 SUPPL-21 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
04/10/2003 SUPPL-20 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
09/27/2002 SUPPL-19 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
12/02/2002 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
12/02/2002 SUPPL-17 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
04/11/2002 SUPPL-16 Manufacturing (CMC)-Facility Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
03/13/2000 SUPPL-15 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
03/13/2000 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
03/13/2000 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
03/13/2000 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
03/13/2000 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
03/13/2000 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/11/1997 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
10/16/1996 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
10/16/1996 SUPPL-7 Manufacturing (CMC)-New Strength Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/03/1996 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/03/1996 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/03/1996 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/03/1996 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/29/1996 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf
07/29/1996 SUPPL-1 Manufacturing (CMC)-New Strength Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/040084s001_thru_028.pdf

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