Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017962
Company: US PHARMS HOLDINGS I
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARLODEL BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription AB Yes No
PARLODEL BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription AB 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
06/28/1978 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/26/2014 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

06/13/2016 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

02/27/2014 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

07/31/2013 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

01/05/2012 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf
01/05/2012 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf
11/09/2005 SUPPL-64 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm
11/09/2005 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm
02/21/2002 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

11/20/2001 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

05/22/2001 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/2000 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

10/01/1999 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

09/10/1999 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/03/1998 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

08/13/1998 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

11/09/1999 SUPPL-53 Labeling

Label is not available on this site.

04/02/1998 SUPPL-52 Labeling

Label is not available on this site.

07/03/1996 SUPPL-51 Labeling

Label is not available on this site.

11/28/1995 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/10/1995 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1995 SUPPL-48 Labeling

Label is not available on this site.

02/08/1995 SUPPL-47 Labeling

Label is not available on this site.

06/09/1995 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1994 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/1995 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1994 SUPPL-42 Labeling

Label is not available on this site.

04/01/1993 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/1992 SUPPL-38 Labeling

Label is not available on this site.

12/11/1991 SUPPL-37 Labeling

Label is not available on this site.

05/29/1992 SUPPL-36 Labeling

Label is not available on this site.

06/09/1992 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1990 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1990 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1990 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1989 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1989 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1990 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/31/1991 SUPPL-27 Labeling

Label is not available on this site.

07/01/1987 SUPPL-25 Labeling

Label is not available on this site.

01/28/1987 SUPPL-22 Labeling

Label is not available on this site.

01/21/1987 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1984 SUPPL-19 Labeling

Label is not available on this site.

06/28/1985 SUPPL-18 Efficacy

Label is not available on this site.

11/30/1983 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1982 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/01/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1984 SUPPL-10 Labeling

Label is not available on this site.

02/06/1981 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1981 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1981 SUPPL-6 Unspecified

Label is not available on this site.

09/23/1981 SUPPL-5 Labeling

Label is not available on this site.

05/17/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/27/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/16/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1980 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/05/2012 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf
01/05/2012 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf
11/09/2005 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf
11/09/2005 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf

PARLODEL

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076962 MYLAN
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077646 PADDOCK LLC
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 074631 SANDOZ INC
PARLODEL BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 017962 US PHARMS HOLDINGS I

CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 077226 MYLAN
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 078899 ZYDUS PHARMS USA INC
PARLODEL BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription Yes AB 017962 US PHARMS HOLDINGS I

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