Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205823
Company: PRINSTON INC
Company: PRINSTON INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | 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 |
---|---|---|---|---|---|---|---|
09/15/2016 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
11/01/2019 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 202725 | AUROBINDO PHARMA LTD |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 076803 | CHARTWELL RX |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077690 | LUPIN |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205823 | PRINSTON INC |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202725 | AUROBINDO PHARMA LTD |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076803 | CHARTWELL RX |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077690 | LUPIN |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205823 | PRINSTON INC |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202725 | AUROBINDO PHARMA LTD |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 076803 | CHARTWELL RX |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077690 | LUPIN |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205823 | PRINSTON INC |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 202725 | AUROBINDO PHARMA LTD |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076803 | CHARTWELL RX |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077690 | LUPIN |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205823 | PRINSTON INC |