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Details for New Drug Application (NDA): 020907
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The generic ingredient in ACTIVELLA is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 020907
Tradename: | ACTIVELLA |
Applicant: | Amneal Pharms Llc |
Ingredient: | estradiol; norethindrone acetate |
Patents: | 0 |
Pharmacology for NDA: 020907
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 020907
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907 | NDA | Gemini Laboratories, LLC | 60846-202 | 60846-202-01 | 1 DIALPACK in 1 CARTON (60846-202-01) > 28 TABLET, FILM COATED in 1 DIALPACK |
ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907 | NDA | Amneal Pharmaceuticals LLC | 60846-232 | 60846-232-01 | 1 BLISTER PACK in 1 CARTON (60846-232-01) > 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG;0.5MG | ||||
Approval Date: | Nov 18, 1998 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG;0.1MG | ||||
Approval Date: | Dec 28, 2006 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020907
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amneal Pharms Llc | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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