Details for New Drug Application (NDA): 206850
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The generic ingredient in ICLEVIA is ethinyl estradiol; levonorgestrel. 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; levonorgestrel profile page.
Summary for 206850
Tradename: | ICLEVIA |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 206850
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ICLEVIA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 206850 | ANDA | Aurobindo Pharma Limited | 65862-865 | 65862-865-83 | 3 POUCH in 1 CARTON (65862-865-83) / 1 BLISTER PACK in 1 POUCH (65862-865-94) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.03MG;0.15MG | ||||
Approval Date: | Jun 29, 2018 | TE: | AB | RLD: | No |
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