Details for New Drug Application (NDA): 214025
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NDA 214025 describes CONJUGATED ESTROGENS, which is a drug marketed by Novast Labs and is included in two NDAs. It is available from one supplier. Additional details are available on the CONJUGATED ESTROGENS profile page.
The generic ingredient in CONJUGATED ESTROGENS is estrogens, conjugated. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.
The generic ingredient in CONJUGATED ESTROGENS is estrogens, conjugated. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.
Summary for 214025
| Tradename: | CONJUGATED ESTROGENS |
| Applicant: | Novast Labs |
| Ingredient: | estrogens, conjugated |
| Patents: | 0 |
Pharmacology for NDA: 214025
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 214025
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CONJUGATED ESTROGENS | estrogens, conjugated | TABLET;ORAL | 214025 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-387 | 50742-387-01 | 100 TABLET, FILM COATED in 1 BOTTLE (50742-387-01) |
| CONJUGATED ESTROGENS | estrogens, conjugated | TABLET;ORAL | 214025 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-387 | 50742-387-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (50742-387-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.3MG | ||||
| Approval Date: | Oct 15, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.45MG | ||||
| Approval Date: | Oct 15, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.625MG | ||||
| Approval Date: | Oct 15, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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