Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019901
Company: KING PHARMS LLC
Company: KING PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALTACE | RAMIPRIL | 1.25MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ALTACE | RAMIPRIL | 2.5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ALTACE | RAMIPRIL | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ALTACE | RAMIPRIL | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/28/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 04/26/2017 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019901s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/19901Orig1s067ltr.pdf | |
| 09/11/2015 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019901s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019901Orig1s065ltr.pdf | |
| 05/02/2014 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019901s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019901Orig1s064ltr.pdf | |
| 10/25/2013 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s063ltr.pdf | |
| 11/04/2013 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s062ltr.pdf | |
| 09/23/2013 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s060ltr.pdf | |
| 04/11/2012 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019901s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019901s059ltr.pdf | |
| 08/23/2011 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019901s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019901s058ltr.pdf | |
| 10/21/2010 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019901s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019901s055ltr.pdf | |
| 02/09/2009 | SUPPL-54 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s054,022021s005ltr.pdf |
| 03/04/2009 | SUPPL-52 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s052,022021s001ltr.pdf |
| 11/15/2004 | SUPPL-46 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019901_s046_altace.pdf |
| 10/15/2004 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s043ltr.pdf |
| 10/15/2004 | SUPPL-41 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s040,041ltr.pdf |
| 10/15/2004 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s040,041ltr.pdf |
| 07/10/2002 | SUPPL-35 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19901scm035ltr.pdf |
| 08/02/2002 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19901slr034ltr.pdf |
| 07/26/2001 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2001 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2000 | SUPPL-28 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019901_s028_Altace.cfm |
| 03/16/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/29/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1998 | SUPPL-25 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19901s025_Altace.pdf |
| 09/24/1998 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/13/1996 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1996 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/05/1995 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/13/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/22/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/22/1995 | SUPPL-10 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/01/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/14/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/20/1993 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/08/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/25/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/18/1992 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1992 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/20/1991 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1991 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/26/2017 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019901s067lbl.pdf | |
| 09/11/2015 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019901s065lbl.pdf | |
| 05/02/2014 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019901s064lbl.pdf | |
| 11/04/2013 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s062lbl.pdf | |
| 10/25/2013 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s063lbl.pdf | |
| 09/23/2013 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s060lbl.pdf | |
| 04/11/2012 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019901s059lbl.pdf | |
| 08/23/2011 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019901s058lbl.pdf | |
| 10/21/2010 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019901s055lbl.pdf |
ALTACE
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 | 202392 | ACCORD HLTHCARE |
| 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 | 202392 | ACCORD HLTHCARE |
| 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 | 202392 | ACCORD HLTHCARE |
| 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 | 202392 | ACCORD HLTHCARE |
| 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 |