Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 085055
Company: JANSSEN PHARMS

Products on ANDA 085055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYLENOL W/ CODEINE NO. 1	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
TYLENOL W/ CODEINE NO. 2	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Discontinued	None	Yes	No
TYLENOL W/ CODEINE NO. 3	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Discontinued	None	Yes	No
TYLENOL W/ CODEINE NO. 4	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/1977	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
10/29/2019	SUPPL-64	Labeling-Package Insert, Labeling-Medication Guide	Label is not available on this site.
11/18/2019	SUPPL-63	Labeling-Package Insert	Label is not available on this site.
05/06/2019	SUPPL-62	Labeling-Package Insert	Label is not available on this site.
09/20/2018	SUPPL-61	Labeling-Package Insert	Label is not available on this site.
09/18/2018	SUPPL-60	REMS - PROPOSAL - D-N-A	Label is not available on this site.
08/29/2017	SUPPL-59	Labeling-Package Insert, Labeling-Medication Guide	Label is not available on this site.
03/24/2017	SUPPL-58	Labeling-Package Insert, Labeling-Medication Guide	Label is not available on this site.
12/16/2016	SUPPL-57	Labeling-Package Insert	Label is not available on this site.
05/06/2019	SUPPL-56	Labeling-Package Insert	Label is not available on this site.
08/15/2014	SUPPL-54	Labeling-Package Insert	Label is not available on this site.
05/10/2013	SUPPL-53	Labeling-Package Insert	Label is not available on this site.
09/15/2011	SUPPL-52	Labeling-Package Insert	Label is not available on this site.
07/11/2008	SUPPL-50	Labeling	Label is not available on this site.
10/31/2007	SUPPL-49	Labeling	Label is not available on this site.
05/31/2001	SUPPL-46	Manufacturing (CMC)-Facility	Label is not available on this site.
11/02/2000	SUPPL-44	Manufacturing (CMC)-Facility	Label is not available on this site.
11/02/2000	SUPPL-43	Manufacturing (CMC)-Facility	Label is not available on this site.
09/23/1994	SUPPL-40	Manufacturing (CMC)	Label is not available on this site.
09/24/1993	SUPPL-39	Manufacturing (CMC)	Label is not available on this site.
11/12/1992	SUPPL-36	Manufacturing (CMC)	Label is not available on this site.
05/07/1991	SUPPL-35	Labeling	Label is not available on this site.
03/15/1991	SUPPL-34	Labeling	Label is not available on this site.
08/31/1990	SUPPL-32	Labeling	Label is not available on this site.
08/31/1990	SUPPL-31	Manufacturing (CMC)	Label is not available on this site.
08/31/1990	SUPPL-30	Manufacturing (CMC)	Label is not available on this site.
12/23/1988	SUPPL-29	Labeling	Label is not available on this site.
12/04/1986	SUPPL-24	Manufacturing (CMC)	Label is not available on this site.
12/04/1986	SUPPL-22	Manufacturing (CMC)	Label is not available on this site.
12/04/1986	SUPPL-21	Manufacturing (CMC)	Label is not available on this site.
10/21/1983	SUPPL-18	Manufacturing (CMC)	Label is not available on this site.
10/21/1983	SUPPL-17	Manufacturing (CMC)	Label is not available on this site.
08/11/1983	SUPPL-15	Manufacturing (CMC)	Label is not available on this site.
12/08/1982	SUPPL-9	Manufacturing (CMC)	Label is not available on this site.
12/08/1982	SUPPL-8	Manufacturing (CMC)	Label is not available on this site.
12/08/1982	SUPPL-7	Manufacturing (CMC)	Label is not available on this site.
12/08/1982	SUPPL-6	Manufacturing (CMC)	Label is not available on this site.
12/30/1981	SUPPL-5	Manufacturing (CMC)	Label is not available on this site.