Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017111
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOBAN MOLINDONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
MOBAN MOLINDONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
MOBAN MOLINDONE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
MOBAN MOLINDONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MOBAN MOLINDONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MOBAN MOLINDONE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MOBAN MOLINDONE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MOBAN MOLINDONE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/18/1974 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017111s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017111Orig1s068ltr.pdf
12/01/2010 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017111s067ltr.pdf
07/19/2009 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017111s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017111s066ltr.pdf
08/14/2008 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s063ltr.pdf
03/12/2008 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s062ltr.pdf
05/22/2001 SUPPL-55 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf
08/21/1998 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1998 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1995 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1995 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1995 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1994 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

08/08/1988 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

06/28/1988 SUPPL-45 Labeling

Label is not available on this site.

06/28/1988 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/23/1987 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/11/1986 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1985 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/19/1982 SUPPL-33 Labeling

Label is not available on this site.

03/24/1981 SUPPL-30 Labeling

Label is not available on this site.

01/06/1981 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/16/1979 SUPPL-28 Labeling

Label is not available on this site.

09/27/1979 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/10/1979 SUPPL-26 Labeling

Label is not available on this site.

12/20/1979 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/05/1981 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/07/1977 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1977 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/07/1977 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/27/1977 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/14/1977 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1976 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/20/1976 SUPPL-7 Labeling

Label is not available on this site.

09/23/1974 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017111s068lbl.pdf
12/01/2010 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf
07/19/2009 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017111s066lbl.pdf
08/14/2008 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s063lbl.pdf
03/12/2008 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s062lbl.pdf

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