Details for New Drug Application (NDA): 215634
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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 215634
Tradename: | PROGESTERONE |
Applicant: | Xiromed |
Ingredient: | progesterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215634
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROGESTERONE | progesterone | INJECTABLE;INJECTION | 215634 | ANDA | XIROMED, LLC | 70700-286 | 70700-286-22 | 10 mL in 1 VIAL, MULTI-DOSE (70700-286-22) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
Approval Date: | Jan 5, 2022 | TE: | AO | RLD: | No |
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