Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020800
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADRENACLICK EPINEPHRINE EQ 0.15MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Prescription BX Yes Yes
ADRENACLICK EPINEPHRINE EQ 0.3MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Prescription BX Yes Yes
TWINJECT 0.15 EPINEPHRINE EQ 0.15MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Discontinued None No No
TWINJECT 0.3 EPINEPHRINE EQ 0.3MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Discontinued None 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
05/30/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20800ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-800_Twinject.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2016 SUPPL-34 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020800Orig1s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020800Orig1s034pkg.pdf
10/17/2014 SUPPL-30 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s030ltr.pdf
10/13/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/23/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/25/2014 SUPPL-27 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s027ltr.pdf
03/25/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/24/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/23/2014 SUPPL-24 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s024ltr.pdf
09/06/2013 SUPPL-23 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020800Orig1s023.pdf
01/26/2011 SUPPL-20 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020800s020ltr.pdf
11/25/2009 SUPPL-18 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf
12/28/2006 SUPPL-11 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020800s011ltr.pdf
07/01/2005 SUPPL-7 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s007ltr.pdf
07/07/2005 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s006ltr.pdf
02/22/2005 SUPPL-5 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20800s005ltr.pdf
05/28/2004 SUPPL-1 Efficacy-New Patient Population Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20800se5-001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/18/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf
05/18/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf
10/17/2014 SUPPL-30 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf
07/25/2014 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf
04/23/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf
04/23/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf
01/26/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
01/26/2011 SUPPL-20 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
01/26/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
01/26/2011 SUPPL-20 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
11/25/2009 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf

ADRENACLICK

There are no Therapeutic Equivalents.

TWINJECT 0.15

There are no Therapeutic Equivalents.

TWINJECT 0.3

There are no Therapeutic Equivalents.

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