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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021945
Company: COVIS

Summary Review

Products on NDA 021945

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAKENA	HYDROXYPROGESTERONE CAPROATE	1250MG/5ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	AP1	Yes	Yes
MAKENA (AUTOINJECTOR)	HYDROXYPROGESTERONE CAPROATE	275MG/1.1ML (250MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
MAKENA PRESERVATIVE FREE	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	AP	Yes	Yes
MAKENA PRESERVATIVE FREE	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021945

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021945s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021945s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021945_makena_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021945Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2018	SUPPL-13		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945s013lbl.pdf
02/14/2018	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021945Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945Orig1s012SumR.pdf
01/26/2017	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/16/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021945s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021945Orig1s008ltr.pdf
02/19/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/15/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/16/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021945s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021945Orig1s005ltr.pdf

Labels for NDA 021945

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2018	SUPPL-13	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945s013lbl.pdf
02/14/2018	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945s012lbl.pdf
08/16/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021945s008lbl.pdf
09/16/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021945s005lbl.pdf
02/03/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021945s000lbl.pdf

Therapeutic Equivalents for NDA 021945

MAKENA

SOLUTION;INTRAMUSCULAR; 1250MG/5ML (250MG/ML)
TE Code = AP1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	1250MG/5ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AP1	211070	EUGIA PHARMA
HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	1250MG/5ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AP1	210618	SLAYBACK PHARMA LLC
HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	1250MG/5ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AP1	208381	SUN PHARM
MAKENA	HYDROXYPROGESTERONE CAPROATE	1250MG/5ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	Yes	AP1	021945	COVIS

MAKENA (AUTOINJECTOR)

There are no Therapeutic Equivalents.

MAKENA PRESERVATIVE FREE

SOLUTION;INTRAMUSCULAR; 250MG/ML (250MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AP	210723	AM REGENT
HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AP	211777	ASPEN
HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AP	211071	EUGIA PHARMA
HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AP	210877	SLAYBACK PHARMA LLC
MAKENA PRESERVATIVE FREE	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	Yes	AP	021945	COVIS

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