Details for New Drug Application (NDA): 214729
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NDA 214729 describes ETYQA, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ETYQA profile page.
The generic ingredient in ETYQA 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 ETYQA 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 214729
| Tradename: | ETYQA |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 214729
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 214729
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETYQA | estradiol; norethindrone acetate | TABLET;ORAL | 214729 | ANDA | Aurobindo Pharma Limited | 59651-424 | 59651-424-28 | 1 BLISTER PACK in 1 CARTON (59651-424-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
| ETYQA | estradiol; norethindrone acetate | TABLET;ORAL | 214729 | ANDA | Aurobindo Pharma Limited | 59651-424 | 59651-424-87 | 1 POUCH in 1 CARTON (59651-424-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG;0.1MG | ||||
| Approval Date: | Jun 30, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG;0.5MG | ||||
| Approval Date: | Jun 30, 2023 | TE: | RLD: | No | |||||
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