Details for New Drug Application (NDA): 211293
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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 211293
Tradename: | ESTRADIOL |
Applicant: | Amneal |
Ingredient: | estradiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211293
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 211293
Suppliers and Packaging for NDA: 211293
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 211293 | ANDA | Amneal Pharmaceuticals LLC | 65162-989 | 65162-989-08 | 8 POUCH in 1 CARTON (65162-989-08) / 1 d in 1 POUCH (65162-989-04) |
ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 211293 | ANDA | Amneal Pharmaceuticals LLC | 65162-992 | 65162-992-08 | 8 POUCH in 1 CARTON (65162-992-08) / 1 d in 1 POUCH (65162-992-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.025MG/24HR | ||||
Approval Date: | Feb 4, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.0375MG/24HR | ||||
Approval Date: | Feb 4, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.05MG/24HR | ||||
Approval Date: | Feb 4, 2019 | TE: | AB1 | RLD: | No |
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