Details for New Drug Application (NDA): 075182
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NDA 075182 describes ESTRADIOL, which is a drug marketed by Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Novitium Pharma, Solaris Pharma Corp, Chemo Research Sl, 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-eight 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 075182
| Tradename: | ESTRADIOL |
| Applicant: | Mylan Technologies |
| Ingredient: | estradiol |
| Patents: | 0 |
Pharmacology for NDA: 075182
| Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 075182
Suppliers and Packaging for NDA: 075182
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 075182 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3349 | 0378-3349-99 | 4 POUCH in 1 CARTON (0378-3349-99) / 1 PATCH in 1 POUCH (0378-3349-16) / 7 d in 1 PATCH |
| ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 075182 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3350 | 0378-3350-99 | 4 POUCH in 1 CARTON (0378-3350-99) / 1 PATCH in 1 POUCH (0378-3350-16) / 7 d in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.1MG/24HR | ||||
| Approval Date: | Feb 24, 2000 | TE: | AB2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.075MG/24HR | ||||
| Approval Date: | Jan 26, 2005 | TE: | AB2 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.025MG/24HR | ||||
| Approval Date: | Jan 26, 2005 | TE: | AB2 | RLD: | No | ||||
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