Details for New Drug Application (NDA): 020375
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NDA 020375 describes CLIMARA, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the CLIMARA profile page.
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.
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 | 020375-006 | May 27, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| 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 | 020375-001 | Dec 22, 1994 | ⤷ 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 | 020375-005 | May 27, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-003 | Mar 23, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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