Details for New Drug Application (NDA): 207506
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NDA 207506 describes AUROVELA 1/20, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the AUROVELA 1/20 profile page.
The generic ingredient in AUROVELA 1/20 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.
The generic ingredient in AUROVELA 1/20 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 207506
| Tradename: | AUROVELA 1/20 |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 207506
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 207506
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUROVELA 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 207506 | ANDA | Aurobindo Pharma Limited | 65862-939 | 65862-939-54 | 5 POUCH in 1 CARTON (65862-939-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
| AUROVELA 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 207506 | ANDA | Aurobindo Pharma Limited | 65862-939 | 65862-939-88 | 3 POUCH in 1 CARTON (65862-939-88) / 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 | 0.02MG;1MG | ||||
| Approval Date: | Jun 16, 2017 | TE: | AB | RLD: | No | ||||
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