Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212041
Company: SCIEGEN PHARMS INC
Company: SCIEGEN 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/15/2020 | ORIG-1 | Approval | STANDARD |
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 |