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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021212
Company: PFIZER

Products on NDA 021212

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021212

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
12/23/2022	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021212s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021212Orig1s018ltr.pdf
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

Labels for NDA 021212

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021212s018lbl.pdf
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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