Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019901
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 079116 APOTEX
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 078745 INVAGEN PHARMS
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 077470 TEVA PHARMS
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 076549 WATSON LABS
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 077900 WEST-WARD PHARMS INT
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 079116 APOTEX
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 078745 INVAGEN PHARMS
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 077470 TEVA PHARMS
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 076549 WATSON LABS
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 077900 WEST-WARD PHARMS INT
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 079116 APOTEX
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 078745 INVAGEN PHARMS
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 077470 TEVA PHARMS
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 076549 WATSON LABS
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 077900 WEST-WARD PHARMS INT
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 079116 APOTEX
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 078745 INVAGEN PHARMS
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 077470 TEVA PHARMS
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 076549 WATSON LABS
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 077900 WEST-WARD PHARMS INT
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 078832 ZYDUS PHARMS USA

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