Details for New Drug Application (NDA): 202985
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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 202985
Tradename: | ESTRADIOL |
Applicant: | Zydus Pharms |
Ingredient: | estradiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202985
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 202985
Suppliers and Packaging for NDA: 202985
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 202985 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-324 | 68382-324-04 | 4 POUCH in 1 CARTON (68382-324-04) / 1 PATCH in 1 POUCH (68382-324-01) / 7 d in 1 PATCH |
ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 202985 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-325 | 68382-325-04 | 4 POUCH in 1 CARTON (68382-325-04) / 1 PATCH in 1 POUCH (68382-325-01) / 7 d in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.025MG/24HR | ||||
Approval Date: | Mar 29, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.0375MG/24HR | ||||
Approval Date: | Mar 29, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.05MG/24HR | ||||
Approval Date: | Mar 29, 2023 | TE: | RLD: | No |
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