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 |
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 |