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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210132


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NDA 210132 describes BIJUVA, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are twenty-four patents protecting this drug. Additional details are available on the BIJUVA profile page.

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 ActionEstrogen 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:RXDosage:CAPSULE;ORALStrength1MG;100MG
Approval Date:Oct 28, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 21, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Nov 21, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Patent:⤷  Sign UpPatent Expiration:Nov 21, 2032Product Flag?YSubstance Flag?Delist Request?

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