Details for New Drug Application (NDA): 020375
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The generic ingredient in CLIMARA is estradiol; levonorgestrel. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; levonorgestrel profile page.
Summary for 020375
Tradename: | CLIMARA |
Applicant: | Bayer Hlthcare |
Ingredient: | estradiol |
Patents: | 0 |
Pharmacology for NDA: 020375
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020375
Suppliers and Packaging for NDA: 020375
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-7104 | 0781-7104-54 | 4 PATCH in 1 CARTON (0781-7104-54) / 7 d in 1 PATCH (0781-7104-58) |
CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-7119 | 0781-7119-54 | 4 PATCH in 1 CARTON (0781-7119-54) / 7 d in 1 PATCH (0781-7119-58) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.05MG/24HR | ||||
Approval Date: | Dec 22, 1994 | TE: | AB2 | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.1MG/24HR | ||||
Approval Date: | Dec 22, 1994 | TE: | AB2 | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.075MG/24HR | ||||
Approval Date: | Mar 23, 1998 | TE: | AB2 | RLD: | Yes |
Expired US Patents for NDA 020375
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-004 | Mar 5, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-006 | May 27, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-003 | Mar 23, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-002 | Dec 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-001 | Dec 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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