Details for New Drug Application (NDA): 211142
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NDA 211142 describes HYDROXYPROGESTERONE CAPROATE, which is a drug marketed by Allergan, Epic Pharma Llc, Aspen Global Inc, and Eugia Pharma, and is included in four NDAs. It is available from one supplier. Additional details are available on the HYDROXYPROGESTERONE CAPROATE profile page.
The generic ingredient in HYDROXYPROGESTERONE CAPROATE is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
The generic ingredient in HYDROXYPROGESTERONE CAPROATE is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
Summary for 211142
| Tradename: | HYDROXYPROGESTERONE CAPROATE |
| Applicant: | Eugia Pharma |
| Ingredient: | hydroxyprogesterone caproate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211142
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 211142 | ANDA | AuroMedics Pharma LLC | 55150-311 | 55150-311-01 | 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIAL |
| HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 211142 | ANDA | AuroMedics Pharma LLC | 55150-311 | 55150-311-05 | 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 1250MG/5ML (250MG/ML) | ||||
| Approval Date: | May 9, 2019 | TE: | RLD: | No | |||||
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