Details for New Drug Application (NDA): 091692
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NDA 091692 describes DOLISHALE, 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 DOLISHALE profile page.
The generic ingredient in DOLISHALE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in DOLISHALE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 091692
| Tradename: | DOLISHALE |
| Applicant: | Novast Labs |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 091692
| Mechanism of Action | Estrogen Receptor Agonists |
| Physiological Effect | Inhibit Ovum Fertilization |
Suppliers and Packaging for NDA: 091692
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOLISHALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 091692 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-659 | 50742-659-28 | 1 BLISTER PACK in 1 CARTON (50742-659-28) / 28 TABLET in 1 BLISTER PACK |
| DOLISHALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 091692 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-659 | 50742-659-68 | 6 BLISTER PACK in 1 CARTON (50742-659-68) / 28 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;0.09MG | ||||
| Approval Date: | Oct 22, 2020 | TE: | AB | RLD: | No | ||||
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