Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017963
Company: US PHARMS HOLDINGS I
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPRESSOR METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription AB Yes No
LOPRESSOR METOPROLOL TARTRATE 100MG TABLET;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
08/07/1978 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
03/21/2016 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017963s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017963Orig1s068ltr.pdf
12/21/2012 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017963Orig1s067ltr.pdf
03/15/2011 SUPPL-64 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017963s064lbl.pdf
11/20/2009 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023ltr.pdf
07/24/2008 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s062,018704s021ltr.pdf
01/08/2008 SUPPL-61 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s061,018704s020ltr.pdf
09/05/2006 SUPPL-59 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018704s018, 017963s059_ltr.pdf
09/12/2003 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18704slr015,17963slr058ltr.pdf
06/14/2002 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/2002 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

07/30/2001 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1999 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/16/1999 SUPPL-51 Labeling

Label is not available on this site.

11/02/1995 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

02/03/1995 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1991 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/14/1990 SUPPL-46 Labeling

Label is not available on this site.

10/26/1989 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/03/1989 SUPPL-43 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/31/1988 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1988 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1985 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/16/1985 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1985 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1985 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1986 SUPPL-34 Efficacy-New Indication

Label is not available on this site.

06/28/1984 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/28/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1984 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/12/1983 SUPPL-28 Efficacy

Label is not available on this site.

05/17/1983 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/14/1982 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/1984 SUPPL-24 Efficacy

Label is not available on this site.

03/26/1982 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/03/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1981 SUPPL-21 Labeling

Label is not available on this site.

01/15/1981 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1981 SUPPL-19 Labeling

Label is not available on this site.

09/03/1980 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1980 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/05/1980 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/12/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1980 SUPPL-12 Labeling

Label is not available on this site.

10/24/1979 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/10/1979 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/27/1979 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/24/1979 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/1979 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/26/1979 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/09/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/09/1979 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1979 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/14/2013 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017963s068lbl.pdf
12/21/2012 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf
03/15/2011 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017963s064lbl.pdf
11/20/2009 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf
07/24/2008 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf

LOPRESSOR

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOPRESSOR METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription Yes AB 017963 US PHARMS HOLDINGS I
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription No AB 202871 ALEMBIC PHARMS LTD
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription No AB 077739 AUROBINDO PHARMA
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription No AB 078459 IPCA LABS LTD
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription No AB 076704 MYLAN
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription No AB 200981 RUBICON
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription No AB 074644 SUN PHARM INDS INC
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Prescription No AB 208955 YOUNGTECH PHARMS INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOPRESSOR METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription Yes AB 017963 US PHARMS HOLDINGS I
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription No AB 202871 ALEMBIC PHARMS LTD
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription No AB 077739 AUROBINDO PHARMA
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription No AB 078459 IPCA LABS LTD
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription No AB 076704 MYLAN
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription No AB 200981 RUBICON
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription No AB 074644 SUN PHARM INDS INC
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Prescription No AB 208955 YOUNGTECH PHARMS INC

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