Details for New Drug Application (NDA): 207581
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The generic ingredient in AUROVELA 1.5/30 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 207581
Tradename: | AUROVELA 1.5/30 |
Applicant: | Aurobindo Pharma |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Pharmacology for NDA: 207581
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 207581
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AUROVELA 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 207581 | ANDA | Aurobindo Pharma Limited | 65862-935 | 65862-935-54 | 5 POUCH in 1 CARTON (65862-935-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
AUROVELA 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 207581 | ANDA | Aurobindo Pharma Limited | 65862-935 | 65862-935-74 | 3 POUCH in 1 CARTON (65862-935-74) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-21 | Strength | 0.03MG;1.5MG | ||||
Approval Date: | Jun 26, 2017 | TE: | AB | RLD: | No |
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