Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078385
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription AB No No
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription AB No 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
10/06/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

07/15/2016 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/06/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/15/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

11/06/2013 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/20/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/08/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/28/2013 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/21/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/30/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 091617 ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 091629 AUROBINDO PHARMA
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 201845 CADISTA PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 201682 IPCA LABS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 078245 LUPIN LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 202289 MACLEODS PHARMS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 091652 MYLAN
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 204901 PRINSTON INC
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 077948 SANDOZ
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 077157 TEVA PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 090528 TORRENT PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 204832 UNICHEM LABS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 077732 WEST-WARD PHARMS INT
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Prescription No AB 078385 ZYDUS PHARMS USA INC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 091617 ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 091629 AUROBINDO PHARMA
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 201845 CADISTA PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 201682 IPCA LABS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 078245 LUPIN LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 202289 MACLEODS PHARMS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 091652 MYLAN
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 204901 PRINSTON INC
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 077948 SANDOZ
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 077157 TEVA PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 090528 TORRENT PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 204832 UNICHEM LABS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 077732 WEST-WARD PHARMS INT
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Prescription No AB 078385 ZYDUS PHARMS USA INC

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