Drugs@FDA: FDA-Approved Drugs
Company: LUPIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | AB | No | No |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | AB | No | No |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
06/09/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077626s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/30/2022 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
04/02/2021 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
02/16/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2014 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2014 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/29/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
08/22/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
RAMIPRIL
CAPSULE;ORAL; 1.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALTACE | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | Yes | AB | 019901 | KING PHARMS LLC |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 091604 | AUROBINDO PHARMA LTD |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 078745 | CHARTWELL MOLECULAR |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 079116 | COREPHARMA |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 078191 | DR REDDYS LABS LTD |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 077900 | HIKMA |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 077626 | LUPIN |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 076549 | WATSON LABS |
RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | No | AB | 078832 | ZYDUS PHARMS USA |
CAPSULE;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALTACE | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 019901 | KING PHARMS LLC |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 091604 | AUROBINDO PHARMA LTD |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 078745 | CHARTWELL MOLECULAR |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 079116 | COREPHARMA |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 078191 | DR REDDYS LABS LTD |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 077900 | HIKMA |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 077626 | LUPIN |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 076549 | WATSON LABS |
RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 078832 | ZYDUS PHARMS USA |
CAPSULE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALTACE | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 019901 | KING PHARMS LLC |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | No | AB | 091604 | AUROBINDO PHARMA LTD |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | No | AB | 078745 | CHARTWELL MOLECULAR |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | No | AB | 079116 | COREPHARMA |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | No | AB | 078191 | DR REDDYS LABS LTD |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | No | AB | 077900 | HIKMA |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | No | AB | 077626 | LUPIN |
RAMIPRIL | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | No | AB | 078832 | ZYDUS PHARMS USA |
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALTACE | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 019901 | KING PHARMS LLC |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 091604 | AUROBINDO PHARMA LTD |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 078745 | CHARTWELL MOLECULAR |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 079116 | COREPHARMA |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 078191 | DR REDDYS LABS LTD |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 077900 | HIKMA |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 077626 | LUPIN |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 076549 | WATSON LABS |
RAMIPRIL | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | No | AB | 078832 | ZYDUS PHARMS USA |