Details for New Drug Application (NDA): 040197
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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 040197
Tradename: | ESTRADIOL |
Applicant: | Barr Labs Inc |
Ingredient: | estradiol |
Patents: | 0 |
Pharmacology for NDA: 040197
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040197
Suppliers and Packaging for NDA: 040197
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | TABLET;ORAL | 040197 | ANDA | Allergan, Inc. | 0430-0720 | 0430-0720-24 | 100 TABLET in 1 BOTTLE (0430-0720-24) |
ESTRADIOL | estradiol | TABLET;ORAL | 040197 | ANDA | Allergan, Inc. | 0430-0721 | 0430-0721-24 | 100 TABLET in 1 BOTTLE (0430-0721-24) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Oct 22, 1997 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Oct 22, 1997 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Oct 22, 1997 | TE: | AB | RLD: | No |
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