Details for New Drug Application (NDA): 203435
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NDA 203435 describes LERIBANE, which is a drug marketed by Novast Labs and is included in one NDA. It is available from one supplier. Additional details are available on the LERIBANE profile page.
The generic ingredient in LERIBANE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in LERIBANE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 203435
| Tradename: | LERIBANE |
| Applicant: | Novast Labs |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 203435
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 203435
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LERIBANE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 203435 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-129 | 75834-129-29 | 3 BLISTER PACK in 1 CARTON (75834-129-29) / 28 TABLET in 1 BLISTER PACK (75834-129-84) |
| LERIBANE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 203435 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-129 | 75834-129-90 | 90 TABLET in 1 BOTTLE (75834-129-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.005MG;1MG | ||||
| Approval Date: | Jun 3, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.0025MG;0.5MG | ||||
| Approval Date: | Jun 3, 2016 | TE: | AB | RLD: | No | ||||
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