Details for New Drug Application (NDA): 210132
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The generic ingredient in BIJUVA is estradiol; progesterone. There are seventy-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estradiol; progesterone profile page.
Summary for 210132
Tradename: | BIJUVA |
Applicant: | Mayne Pharma |
Ingredient: | estradiol; progesterone |
Patents: | 24 |
Pharmacology for NDA: 210132
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 210132
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132 | NDA | Mayne Pharma LLC | 50261-211 | 50261-211-05 | 1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK |
BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132 | NDA | Mayne Pharma LLC | 50261-211 | 50261-211-30 | 1 BLISTER PACK in 1 CARTON (50261-211-30) / 30 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MG;100MG | ||||
Approval Date: | Oct 28, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 21, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 21, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 21, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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