Details for New Drug Application (NDA): 021367
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The generic ingredient in FEMRING is estradiol acetate. There is one drug master file entry 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 Mfg Pr |
| Ingredient: | estradiol acetate |
| Patents: | 0 |
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 Mfg Pr | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-001 | Mar 20, 2003 | 5,855,906 | ⤷ Start Trial |
| Millicent Mfg Pr | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-002 | Mar 20, 2003 | 5,855,906 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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