Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021945
Company: COVIS
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 |