Details for New Drug Application (NDA): 017362
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NDA 017362 describes PROGESTERONE, which is a drug marketed by Amneal Pharms Ny, Bionpharma, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, and Lilly, and is included in fifteen NDAs. It is available from twenty-one suppliers. Additional details are available on the PROGESTERONE profile page.
The generic ingredient in PROGESTERONE is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.
The generic ingredient in PROGESTERONE is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 017362
| Tradename: | PROGESTERONE |
| Applicant: | Actavis Labs Ut Inc |
| Ingredient: | progesterone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017362
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROGESTERONE | progesterone | INJECTABLE;INJECTION | 017362 | NDA | Actavis Pharma, Inc. | 0591-3128 | 0591-3128-79 | 10 mL in 1 VIAL, MULTI-DOSE (0591-3128-79) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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