Details for New Drug Application (NDA): 075803
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The generic ingredient in LESSINA-28 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 075803
Tradename: | LESSINA-28 |
Applicant: | Barr |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 075803
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LESSINA-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 075803 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9014 | 0555-9014-67 | 3 POUCH in 1 CARTON (0555-9014-67) / 1 BLISTER PACK in 1 POUCH (0555-9014-79) / 1 KIT in 1 BLISTER PACK |
LESSINA-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075803 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9014 | 0555-9014-67 | 3 POUCH in 1 CARTON (0555-9014-67) / 1 BLISTER PACK in 1 POUCH (0555-9014-79) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.02MG;0.1MG | ||||
Approval Date: | Mar 20, 2002 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;0.1MG | ||||
Approval Date: | Mar 20, 2002 | TE: | AB2 | RLD: | No |
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