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Details for New Drug Application (NDA): 021945
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NDA 021945 describes MAKENA (AUTOINJECTOR), which is a drug marketed by Covis and is included in one NDA. It is available from two suppliers. There are eight 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. Seven suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
The generic ingredient in MAKENA (AUTOINJECTOR) is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Seven 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: | 8 |
| 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 |
Paragraph IV (Patent) Challenges for 021945
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MAKENA | SOLUTION;INTRAMUSCULAR | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
| MAKENA PRESERVATIVE FREE | SOLUTION;INTRAMUSCULAR | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
| MAKENA (AUTOINJECTOR) | SOLUTION;SUBCUTANEOUS | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
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: | ⤷ Free Forever Trial | 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 | ⤷ Free Forever Trial | ⤷ Free Forever Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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