Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075944
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| 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 | 40MG | TABLET;ORAL | Prescription | AB | No | No |
| LISINOPRIL | LISINOPRIL | 30MG | 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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75944ta2.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/27/2020 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/16/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/05/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/05/2013 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/05/2013 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/05/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/12/2010 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/08/2010 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/22/2010 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/24/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/11/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/11/2003 | SUPPL-1 | Manufacturing (CMC)-New Strength |
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 | 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; 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; 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 |