Details for New Drug Application (NDA): 021945
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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 |
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
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 |
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