Details for New Drug Application (NDA): 021945

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

NDA 021945 describes MAKENA (AUTOINJECTOR), which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the MAKENA (AUTOINJECTOR) profile page.

The generic ingredient in MAKENA (AUTOINJECTOR) is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.

Summary for 021945

Tradename:	MAKENA (AUTOINJECTOR)
Applicant:	Covis
Ingredient:	hydroxyprogesterone caproate
Patents:	12
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021945

Suppliers and Packaging for NDA: 021945

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MAKENA	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	021945	NDA	AMAG Pharmaceuticals, Inc.	64011-243	64011-243-01	1 VIAL, GLASS in 1 CARTON (64011-243-01) / 5 mL in 1 VIAL, GLASS
MAKENA PRESERVATIVE FREE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	021945	NDA	AMAG Pharmaceuticals, Inc.	64011-243	64011-243-01	1 VIAL, GLASS in 1 CARTON (64011-243-01) / 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	1250MG/5ML (250MG/ML)
Approval Date:	Feb 3, 2011	TE:	AP1	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	250MG/ML (250MG/ML)
Approval Date:	Feb 19, 2016	TE:	AP	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	275MG/1.1ML (250MG/ML)
Approval Date:	Feb 14, 2018	TE:		RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	May 2, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	REDUCING THE RISK OF PRETERM BIRTH IN WOMEN WITH A SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH

Expired US Patents for NDA 021945

Subscribe to access the full database, or Try it Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	MAKENA (AUTOINJECTOR)	hydroxyprogesterone caproate	SOLUTION;SUBCUTANEOUS	021945-004	Feb 14, 2018	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.