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Details for New Drug Application (NDA): 020907
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NDA 020907 describes ACTIVELLA, which is a drug marketed by Amneal Pharms Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the ACTIVELLA profile page.
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.
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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