Details for New Drug Application (NDA): 021371
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The generic ingredient in ESTRASORB is estradiol hemihydrate. There is one drug master file entry for this compound. Additional details are available on the estradiol hemihydrate profile page.
Summary for 021371
| Tradename: | ESTRASORB |
| Applicant: | Exeltis Usa Inc |
| Ingredient: | estradiol hemihydrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | EMULSION;TOPICAL | Strength | 0.25% | ||||
| Approval Date: | Oct 9, 2003 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021371
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Exeltis Usa Inc | ESTRASORB | estradiol hemihydrate | EMULSION;TOPICAL | 021371-001 | Oct 9, 2003 | 5,629,021 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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