Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021212
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAVERJECT IMPULSE ALPROSTADIL 0.01MG/VIAL INJECTABLE;INJECTION Prescription None No No
CAVERJECT IMPULSE ALPROSTADIL 0.02MG/VIAL INJECTABLE;INJECTION Prescription 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
06/11/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21212lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21212ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-212_Caverject.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s015,s016ltr.pdf
10/25/2016 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s015,s016ltr.pdf
05/05/2016 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s014ltr.pdf
12/01/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021212s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021212Orig1s011ltr.pdf
06/11/2014 SUPPL-10 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021212Orig1s010ltr.pdf
12/19/2013 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021212s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021212Orig1s007ltr.pdf
09/02/2003 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr005,21212slr002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2016 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf
10/25/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf
05/05/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s014lbl.pdf
10/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021212s011lbl.pdf
12/19/2013 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021212s007lbl.pdf
06/11/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21212lbl.pdf

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