Details for New Drug Application (NDA): 021367
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The generic ingredient in FEMRING is estradiol acetate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.
Summary for 021367
Tradename: | FEMRING |
Applicant: | Millicent |
Ingredient: | estradiol acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021367
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 021367
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367 | NDA | Millicent US, Inc. | 72495-201 | 72495-201-05 | 1 POUCH in 1 CARTON (72495-201-05) / 90 d in 1 POUCH |
FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367 | NDA | Millicent US, Inc. | 72495-202 | 72495-202-10 | 1 POUCH in 1 CARTON (72495-202-10) / 90 d in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INSERT, EXTENDED RELEASE;VAGINAL | Strength | EQ 0.05MG BASE/24HR | ||||
Approval Date: | Mar 20, 2003 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INSERT, EXTENDED RELEASE;VAGINAL | Strength | EQ 0.1MG BASE/24HR | ||||
Approval Date: | Mar 20, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 021367
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Millicent | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-001 | Mar 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Millicent | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-002 | Mar 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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