Details for New Drug Application (NDA): 216558
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NDA 216558 describes OSHIH, 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 OSHIH profile page.
The generic ingredient in OSHIH is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in OSHIH is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 216558
| Tradename: | OSHIH |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSHIH | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 216558 | ANDA | Aurobindo Pharma Limited | 59651-504 | 59651-504-88 | 3 POUCH in 1 CARTON (59651-504-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.02MG;1MG | ||||
| Approval Date: | Dec 6, 2023 | TE: | RLD: | No | |||||
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