Details for New Drug Application (NDA): 021166
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NDA 021166 describes ESTROGEL, which is a drug marketed by Ascend Theraps Us and is included in one NDA. It is available from one supplier. Additional details are available on the ESTROGEL profile page.
The generic ingredient in ESTROGEL is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
The generic ingredient in ESTROGEL is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 021166
| Tradename: | ESTROGEL |
| Applicant: | Ascend Theraps Us |
| Ingredient: | estradiol |
| Patents: | 0 |
Pharmacology for NDA: 021166
| Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021166
Suppliers and Packaging for NDA: 021166
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTROGEL | estradiol | GEL, METERED;TRANSDERMAL | 021166 | NDA | ASCEND Therapeutics US, LLC | 17139-617 | 17139-617-40 | 50 g in 1 BOTTLE, PUMP (17139-617-40) |
| ESTROGEL | estradiol | GEL;TOPICAL | 021166 | NDA | ASCEND Therapeutics US, LLC | 17139-617 | 17139-617-40 | 50 g in 1 BOTTLE, PUMP (17139-617-40) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | GEL;TOPICAL | Strength | 0.06% | ||||
| Approval Date: | Feb 9, 2004 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 0.06% (1.25GM/ACTIVATION) | ||||
| Approval Date: | Feb 9, 2004 | TE: | AB | RLD: | Yes | ||||
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