Details for New Drug Application (NDA): 216796
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NDA 216796 describes EMZAHH, 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 EMZAHH profile page.
The generic ingredient in EMZAHH is norethindrone. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
The generic ingredient in EMZAHH is norethindrone. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 216796
| Tradename: | EMZAHH |
| Applicant: | Aurobindo Pharma |
| Ingredient: | norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216796
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMZAHH | norethindrone | TABLET;ORAL-28 | 216796 | ANDA | Aurobindo Pharma Limited | 59651-136 | 59651-136-28 | 1 BLISTER PACK in 1 CARTON (59651-136-28) / 1 TABLET in 1 BLISTER PACK |
| EMZAHH | norethindrone | TABLET;ORAL-28 | 216796 | ANDA | Aurobindo Pharma Limited | 59651-136 | 59651-136-88 | 3 POUCH in 1 CARTON (59651-136-88) / 1 TABLET in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
| Approval Date: | Jan 6, 2023 | TE: | AB2 | RLD: | No | ||||
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