Details for New Drug Application (NDA): 216524
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NDA 216524 describes ESTRADIOL, which is a drug marketed by Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Solaris Pharma Corp, Chemo Research Sl, Novitium Pharma, Quagen, Ortho Mcneil Pharm, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Norvium Bioscience, Usl Pharma, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Xiromed, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in forty-seven NDAs. It is available from thirty-six suppliers. Additional details are available on the ESTRADIOL profile page.
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.
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 216524
| Tradename: | ESTRADIOL |
| Applicant: | Padagis Israel |
| Ingredient: | estradiol |
| Patents: | 0 |
Pharmacology for NDA: 216524
| Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 216524
Suppliers and Packaging for NDA: 216524
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | estradiol | GEL;TRANSDERMAL | 216524 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-134 | 45802-134-30 | 30 PACKET in 1 CARTON (45802-134-30) / .25 g in 1 PACKET |
| ESTRADIOL | estradiol | GEL;TRANSDERMAL | 216524 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-202 | 45802-202-30 | 30 PACKET in 1 CARTON (45802-202-30) / .5 g in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 0.1% (0.25GM/PACKET) | ||||
| Approval Date: | Nov 14, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 0.1% (0.5GM/PACKET) | ||||
| Approval Date: | Nov 14, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 0.1% (0.75GM/PACKET) | ||||
| Approval Date: | Nov 14, 2023 | TE: | AB | RLD: | No | ||||
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