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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021583
Company: PFIZER

Products on NDA 021583

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEPO-SUBQ PROVERA 104	MEDROXYPROGESTERONE ACETATE	104MG/0.65ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021583ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021583s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2020	SUPPL-34	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021583Orig1s033, s034ltr.pdf
12/04/2020	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021583Orig1s033, s034ltr.pdf
10/14/2016	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s032ltr.pdf
12/16/2016	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s031ltr.pdf
12/23/2019	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf
08/04/2016	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/23/2015	SUPPL-26	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583Orig1s026ltr.pdf
01/30/2015	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021583Orig1s025ltr.pdf
12/23/2019	SUPPL-24	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf
01/31/2017	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021583s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021583Orig1s023ltr.pdf
03/01/2018	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021583s17ltr.pdf
12/23/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf
02/29/2016	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/15/2009	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021583s011ltr.pdf
10/05/2007	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021583s006ltr.pdf
11/08/2005	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s003ltr.pdf
05/02/2005	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s001ltr.pdf

Labels for NDA 021583

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2020	SUPPL-34	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf
12/04/2020	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf
12/23/2019	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf
12/23/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf
12/23/2019	SUPPL-24	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf
12/23/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf
01/31/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021583s023lbl.pdf
12/16/2016	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf
10/14/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s032lbl.pdf
01/30/2015	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf
01/23/2015	SUPPL-26	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf
07/15/2009	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf
10/05/2007	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf
11/08/2005	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf
12/17/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf

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