Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021945
Company: COVIS

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

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

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

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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