Details for New Drug Application (NDA): 204379
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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 204379
Tradename: | ESTRADIOL |
Applicant: | Zydus Pharms |
Ingredient: | estradiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204379
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 204379
Suppliers and Packaging for NDA: 204379
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 204379 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-323 | 68382-323-04 | 4 POUCH in 1 CARTON (68382-323-04) / 1 PATCH in 1 POUCH (68382-323-01) / 7 d in 1 PATCH |
ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 204379 | ANDA | Zydus Lifesciences Limited | 70771-1400 | 70771-1400-4 | 4 POUCH in 1 CARTON (70771-1400-4) / 1 PATCH in 1 POUCH (70771-1400-1) / 7 d in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 0.014MG/24HR | ||||
Approval Date: | Apr 17, 2023 | TE: | AB | RLD: | No |
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