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Details for New Drug Application (NDA): 021945
NDA 021945 describes MAKENA (AUTOINJECTOR), which is a drug marketed by Amag Pharma Usa 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
Summary for 021945
| Tradename: | MAKENA (AUTOINJECTOR) |
| Applicant: | Amag Pharma Usa |
| Ingredient: | hydroxyprogesterone caproate |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021945
| Ingredient-type | Progesterone Congeners |
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 3, 2018 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF PRETERM BIRTH IN WOMEN WITH SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH | ||||||||
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 | ||||
| Regulatory Exclusivity Expiration: | Feb 3, 2018 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF PRETERM BIRTH IN WOMEN WITH SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH | ||||||||
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: | ➤ Sign Up | Patent Expiration: | Oct 4, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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