Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040201
Company: MALLINCKRODT

Products on ANDA 040201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40201ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2011	SUPPL-29	Labeling		Label is not available on this site.
11/13/2002	SUPPL-11	Labeling		Label is not available on this site.
09/27/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
08/05/2002	SUPPL-9	Labeling		Label is not available on this site.
08/05/2002	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/11/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
04/25/2000	SUPPL-6	Labeling		Label is not available on this site.
04/25/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/25/2000	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/25/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/25/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/25/2000	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.