Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018303
Company: US PHARMS HOLDINGS I
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET;ORAL Prescription AB Yes No
LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET;ORAL Prescription AB Yes Yes
LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/31/1984 ORIG-1 Approval Type 4 - New Combination 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
08/20/2020 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018303s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018303Orig1s041ltr.pdf
03/15/2011 SUPPL-36 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf
03/15/2011 SUPPL-35 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf
08/07/2009 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018303s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018303s034ltr.pdf
07/24/2008 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s033ltr.pdf
01/08/2008 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s032ltr.pdf
09/07/2006 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018303s029_ltr.pdf
10/31/2003 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18303slr025ltr.pdf
06/14/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/2002 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/08/2002 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/12/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1999 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 SUPPL-16 Labeling

Label is not available on this site.

01/08/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/31/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1995 SUPPL-11 Labeling

Label is not available on this site.

11/08/1991 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/18/1991 SUPPL-9 Labeling

Label is not available on this site.

06/14/1990 SUPPL-8 Labeling

Label is not available on this site.

12/09/1988 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/23/1988 SUPPL-5 Labeling

Label is not available on this site.

05/31/1988 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1985 SUPPL-2 Labeling

Label is not available on this site.

03/26/1985 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
08/20/2020 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018303s041lbl.pdf
03/15/2011 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf
03/15/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf
08/07/2009 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018303s034lbl.pdf
07/24/2008 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s033lbl.pdf
01/08/2008 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf

LOPRESSOR HCT

TABLET;ORAL; 25MG;50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET;ORAL Prescription Yes AB 018303 US PHARMS HOLDINGS I
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET;ORAL Prescription No AB 202870 ALEMBIC PHARMS LTD
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET;ORAL Prescription No AB 076792 MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET;ORAL Prescription No AB 090654 SUN PHARM INDS

TABLET;ORAL; 25MG;100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET;ORAL Prescription Yes AB 018303 US PHARMS HOLDINGS I
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET;ORAL Prescription No AB 202870 ALEMBIC PHARMS LTD
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET;ORAL Prescription No AB 076792 MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET;ORAL Prescription No AB 090654 SUN PHARM INDS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English