Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088991
Company: MALLINCKRODT

Products on ANDA 088991

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUCET	ACETAMINOPHEN; BUTALBITAL	650MG;50MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088991

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/1985	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/1996	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/29/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/12/1994	SUPPL-16	Labeling		Label is not available on this site.
04/12/1994	SUPPL-15	Labeling		Label is not available on this site.
03/20/1992	SUPPL-14	Labeling		Label is not available on this site.
02/27/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/05/1989	SUPPL-12	Labeling		Label is not available on this site.
08/18/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/11/1989	SUPPL-10	Labeling		Label is not available on this site.
04/08/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/27/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/07/1989	SUPPL-7	Labeling		Label is not available on this site.
02/07/1989	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/07/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/07/1989	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/07/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.