Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040418
Company: MALLINCKRODT

Products on ANDA 040418

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG/15ML;7.5MG/15ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone%20.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone%20.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone%20.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2008	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 040418

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40-418_Hydrocdone%20.pdf