Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 018354
Company: ORTHO MCNEIL JANSSEN

Products on NDA 018354

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORTHO-NOVUM 10/11-21	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL-21	Discontinued	None	Yes	No
ORTHO-NOVUM 10/11-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG;0.5MG,1MG	TABLET;ORAL-28	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018354

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/1982	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
06/03/2002	SUPPL-43	Manufacturing (CMC)-Control	Label is not available on this site.
02/21/2002	SUPPL-42	Manufacturing (CMC)	Label is not available on this site.
07/09/2001	SUPPL-41	Manufacturing (CMC)-Control	Label is not available on this site.
03/13/2009	SUPPL-40	Labeling	Label is not available on this site.
01/05/2000	SUPPL-39	Manufacturing (CMC)-Packaging	Label is not available on this site.
01/21/2000	SUPPL-38	Labeling	Label is not available on this site.
08/27/1999	SUPPL-37	Labeling	Label is not available on this site.
04/28/1998	SUPPL-36	Manufacturing (CMC)	Label is not available on this site.
04/13/1998	SUPPL-35	Manufacturing (CMC)	Label is not available on this site.
08/27/1999	SUPPL-34	Labeling	Label is not available on this site.
01/29/1997	SUPPL-33	Manufacturing (CMC)	Label is not available on this site.
02/24/1997	SUPPL-32	Manufacturing (CMC)-Control	Label is not available on this site.
04/09/1996	SUPPL-31	Manufacturing (CMC)-Control	Label is not available on this site.
05/10/1996	SUPPL-30	Manufacturing (CMC)-Control	Label is not available on this site.
11/30/1995	SUPPL-29	Manufacturing (CMC)	Label is not available on this site.
09/07/1995	SUPPL-28	Manufacturing (CMC)-Control	Label is not available on this site.
02/16/1995	SUPPL-27	Manufacturing (CMC)-Control	Label is not available on this site.
07/06/1994	SUPPL-26	Labeling	Label is not available on this site.
11/04/1993	SUPPL-25	Manufacturing (CMC)	Label is not available on this site.
05/18/1993	SUPPL-24	Manufacturing (CMC)-Control	Label is not available on this site.
03/07/1994	SUPPL-23	Manufacturing (CMC)-Formulation	Label is not available on this site.
03/18/1991	SUPPL-21	Manufacturing (CMC)-Control	Label is not available on this site.
09/16/1991	SUPPL-20	Labeling	Label is not available on this site.
01/18/1990	SUPPL-19	Manufacturing (CMC)-Control	Label is not available on this site.
10/23/1989	SUPPL-17	Labeling	Label is not available on this site.
07/19/1989	SUPPL-16	Labeling	Label is not available on this site.
10/28/1988	SUPPL-15	Manufacturing (CMC)-Control	Label is not available on this site.
06/08/1988	SUPPL-14	Manufacturing (CMC)	Label is not available on this site.
09/09/1988	SUPPL-13	Labeling	Label is not available on this site.
02/26/1987	SUPPL-12	Labeling	Label is not available on this site.
11/23/1987	SUPPL-11	Manufacturing (CMC)-Control	Label is not available on this site.
03/13/2009	SUPPL-10	Labeling	Label is not available on this site.
10/21/1985	SUPPL-9	Labeling	Label is not available on this site.
04/05/1985	SUPPL-8	Labeling	Label is not available on this site.
06/21/1984	SUPPL-7	Labeling	Label is not available on this site.
01/30/1984	SUPPL-6	Labeling	Label is not available on this site.
09/29/1983	SUPPL-5	Labeling	Label is not available on this site.
06/15/1983	SUPPL-3	Labeling	Label is not available on this site.
06/09/1983	SUPPL-2	Manufacturing (CMC)-Control	Label is not available on this site.
03/13/2009	SUPPL-1	Labeling	Label is not available on this site.