Details for New Drug Application (NDA): 206685
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The generic ingredient in ESTRADIOL is estradiol valerate. There are seventy-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.
Summary for 206685
Tradename: | ESTRADIOL |
Applicant: | Mylan Technologies |
Ingredient: | estradiol |
Patents: | 0 |
Pharmacology for NDA: 206685
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206685
Suppliers and Packaging for NDA: 206685
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 206685 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4619 | 0378-4619-26 | 8 POUCH in 1 CARTON (0378-4619-26) / 1 PATCH in 1 POUCH (0378-4619-16) / 3.5 d in 1 PATCH |
ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 206685 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4620 | 0378-4620-26 | 8 POUCH in 1 CARTON (0378-4620-26) / 1 PATCH in 1 POUCH (0378-4620-16) / 3.5 d in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.025MG/24HR | ||||
Approval Date: | Aug 15, 2018 | TE: | AB3 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.0375MG/24HR | ||||
Approval Date: | Aug 15, 2018 | TE: | AB3 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.05MG/24HR | ||||
Approval Date: | Aug 15, 2018 | TE: | AB3 | RLD: | No |
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