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.
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 | 50261-251 | 50261-251-05 | 1 BLISTER PACK in 1 CARTON (50261-251-05) / 5 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: | 10,052,386 | Patent Expiration: | Nov 21, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,206,932 | Patent Expiration: | Nov 21, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS | ||||||||
| Patent: | 10,639,375 | Patent Expiration: | Nov 21, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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