Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019777
Company: TWI PHARMS
Company: TWI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZESTRIL | LISINOPRIL | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZESTRIL | LISINOPRIL | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZESTRIL | LISINOPRIL | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZESTRIL | LISINOPRIL | 40MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| ZESTRIL | LISINOPRIL | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZESTRIL | LISINOPRIL | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/19/1988 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 07/21/2017 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019777s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019777Orig1s076ltr.pdf | |
| 04/21/2016 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019777s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019777Orig1s074ltr.pdf | |
| 08/25/2015 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019777s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019777Orig1s073ltr.pdf | |
| 12/24/2014 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s064ltr.pdf | |
| 11/05/2013 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019777s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019777Orig1s063ltr.pdf | |
| 08/13/2012 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s062ltr.pdf | |
| 10/31/2012 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s061ltr.pdf | |
| 03/29/2012 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s060ltr.pdf | |
| 05/02/2012 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s059ltr.pdf | |
| 08/04/2011 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019777s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019777s058ltr.pdf | |
| 06/26/2014 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s057ltr.pdf | |
| 11/06/2009 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s056ltr.pdf | |
| 05/20/2009 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s054ltr.pdf | |
| 10/04/2007 | SUPPL-53 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s053, 019888s044ltr.pdf |
| 07/16/2007 | SUPPL-52 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s052, 019888s043ltr.pdf |
| 06/16/2006 | SUPPL-50 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019777s050, 019888s041LTR.pdf |
| 05/24/2005 | SUPPL-49 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019777s049ltr.pdf |
| 10/17/2002 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 07/01/2003 | SUPPL-44 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-044,slr042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-777S042S044_Zestril.cfm | |
| 03/30/2004 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19777slr043ltr.pdf |
| 07/01/2003 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-044,slr042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-777S042S044_Zestril.cfm | |
| 12/15/2000 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2000 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/2000 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1999 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/2000 | SUPPL-37 | Efficacy-New Indication |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19777S37LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19777s037.pdf |
| 02/24/1999 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/1999 | SUPPL-35 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19777-s035_Zestril.pdf |
| 11/06/1998 | SUPPL-34 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19777-s034_zestril.pdf |
| 05/01/1998 | SUPPL-33 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19777-s033_zestril.pdf |
| 01/08/1997 | SUPPL-32 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019777ap.pdf |
| 10/11/1996 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S31_ZestrilTablets_toc.cfm |
| 11/15/1995 | SUPPL-30 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S30_ZestrilTablets_toc.cfm |
| 10/26/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1995 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S27_ZestrilTablets_toc.cfm |
| 07/11/1995 | SUPPL-26 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S26_ZestrilTablets_toc.cfm |
| 03/31/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/05/1995 | SUPPL-24 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S24_ZestrilTablets_toc.cfm |
| 11/24/1995 | SUPPL-23 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/17/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/23/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/31/1993 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19888-S12_Zestril.pdf |
| 05/26/1993 | SUPPL-17 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S17_ZestrilTablets_toc.cfm |
| 04/29/1993 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/18/1992 | SUPPL-15 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S15_ZestrilTablets_toc.cfm |
| 06/25/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/12/1992 | SUPPL-13 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S13_ZestrilTablets_toc.cfm |
| 12/11/1991 | SUPPL-12 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S12_Zestril_toc.cfm |
| 07/29/1991 | SUPPL-11 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S11_ZestrilTablets_toc.cfm |
| 04/11/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/17/1990 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S9_Zestril.pdf |
| 11/08/1990 | SUPPL-8 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S8_ZestrilTablets_toc.cfm |
| 06/09/1993 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/05/1989 | SUPPL-6 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S6_ZestrilTablets_toc.cfm |
| 07/20/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/11/1989 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S4_Zestril.pdf |
| 01/18/1989 | SUPPL-3 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S3_Zestril.pdf |
| 09/20/1988 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S2_ZestrilTablets_toc.cfm |
| 06/30/1988 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S1_Zestril.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/21/2017 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019777s076lbl.pdf | |
| 04/21/2016 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019777s074lbl.pdf | |
| 08/25/2015 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019777s073lbl.pdf | |
| 12/24/2014 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s064lbl.pdf | |
| 06/26/2014 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s057lbl.pdf | |
| 11/05/2013 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019777s063lbl.pdf | |
| 10/31/2012 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s061lbl.pdf | |
| 08/13/2012 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s062lbl.pdf | |
| 05/02/2012 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s059lbl.pdf | |
| 03/29/2012 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s060lbl.pdf | |
| 08/04/2011 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019777s058lbl.pdf | |
| 11/06/2009 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s056lbl.pdf | |
| 05/20/2009 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s054lbl.pdf | |
| 07/01/2003 | SUPPL-44 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf | |
| 07/01/2003 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf |
ZESTRIL
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 | 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 | 212041 | SCIEGEN PHARMS 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 | 078402 | WOCKHARDT BIO AG |
| ZESTRIL | LISINOPRIL | 5MG | TABLET;ORAL | Prescription | Yes | AB | 019777 | TWI PHARMS |
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 | 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 | 212041 | SCIEGEN PHARMS 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 | 078402 | WOCKHARDT BIO AG |
| ZESTRIL | LISINOPRIL | 10MG | TABLET;ORAL | Prescription | Yes | AB | 019777 | TWI PHARMS |
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 | 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 | 208920 | SCIEGEN PHARMS 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 | 078402 | WOCKHARDT BIO AG |
| ZESTRIL | LISINOPRIL | 20MG | TABLET;ORAL | Prescription | Yes | AB | 019777 | TWI PHARMS |
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 | 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 | 208920 | SCIEGEN PHARMS 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 | 078402 | WOCKHARDT BIO AG |
| ZESTRIL | LISINOPRIL | 40MG | TABLET;ORAL | Prescription | Yes | AB | 019777 | TWI PHARMS |
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 | 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 | 212041 | SCIEGEN PHARMS 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 | 078402 | WOCKHARDT BIO AG |
| ZESTRIL | LISINOPRIL | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 019777 | TWI PHARMS |
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 | 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 | 208920 | SCIEGEN PHARMS 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 | 078402 | WOCKHARDT BIO AG |
| ZESTRIL | LISINOPRIL | 30MG | TABLET;ORAL | Prescription | Yes | AB | 019777 | TWI PHARMS |