Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075903
Company: ASCENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 40MG 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
07/01/2002 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
08/17/2021 SUPPL-21 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/27/2020 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

05/07/2010 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

12/01/2009 SUPPL-18 Labeling

Label is not available on this site.

12/01/2009 SUPPL-17 Labeling

Label is not available on this site.

07/03/2006 SUPPL-15 Labeling

Label is not available on this site.

02/13/2007 SUPPL-14 Labeling

Label is not available on this site.

10/25/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

LISINOPRIL

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075903 ASCENT PHARMS INC
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 078402 ATLANTIDE
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075994 CHARTWELL RX
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076102 COREPHARMA
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 212041 YILING
ZESTRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription Yes AB 019777 ALMATICA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075903 ASCENT PHARMS INC
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 078402 ATLANTIDE
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075994 CHARTWELL RX
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076102 COREPHARMA
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 212041 YILING
PRINIVIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 019558 MERCK
ZESTRIL LISINOPRIL 5MG TABLET;ORAL Prescription Yes AB 019777 ALMATICA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075903 ASCENT PHARMS INC
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 078402 ATLANTIDE
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075994 CHARTWELL RX
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076102 COREPHARMA
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 212041 YILING
ZESTRIL LISINOPRIL 10MG TABLET;ORAL Prescription Yes AB 019777 ALMATICA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075903 ASCENT PHARMS INC
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 078402 ATLANTIDE
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075994 CHARTWELL RX
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076102 COREPHARMA
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 208920 YILING
ZESTRIL LISINOPRIL 20MG TABLET;ORAL Prescription Yes AB 019777 ALMATICA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075903 ASCENT PHARMS INC
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 078402 ATLANTIDE
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075994 CHARTWELL RX
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076102 COREPHARMA
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 208920 YILING
ZESTRIL LISINOPRIL 30MG TABLET;ORAL Prescription Yes AB 019777 ALMATICA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075903 ASCENT PHARMS INC
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 078402 ATLANTIDE
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075994 CHARTWELL RX
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076102 COREPHARMA
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 208920 YILING
PRINIVIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 019558 MERCK
ZESTRIL LISINOPRIL 40MG TABLET;ORAL Prescription Yes AB 019777 ALMATICA

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