Details for New Drug Application (NDA): 091408
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NDA 091408 describes KURVELO, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the KURVELO profile page.
The generic ingredient in KURVELO is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in KURVELO is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 091408
| Tradename: | KURVELO |
| Applicant: | Lupin Ltd |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091408
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KURVELO | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091408 | ANDA | A-S Medication Solutions | 50090-6374 | 50090-6374-0 | 1 KIT in 1 CARTON (50090-6374-0) * 21 TABLET in 1 BLISTER PACK (68180-841-74) * 7 TABLET in 1 BLISTER PACK (68180-842-74) |
| KURVELO | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091408 | ANDA | LUPIN LIMITED | 57297-844 | 57297-844-73 | 3 BLISTER PACK in 1 CARTON (57297-844-73) / 1 KIT in 1 BLISTER PACK (57297-844-71) * 21 TABLET in 1 BLISTER PACK (57297-841-74) * 7 TABLET in 1 BLISTER PACK (57297-842-74) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.15MG | ||||
| Approval Date: | Oct 17, 2012 | TE: | AB | RLD: | No | ||||
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