Details for New Drug Application (NDA): 091467
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NDA 091467 describes DAYSEE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the DAYSEE profile page.
The generic ingredient in DAYSEE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in DAYSEE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 091467
| Tradename: | DAYSEE |
| Applicant: | Lupin Ltd |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091467
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAYSEE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 091467 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-846 | 68180-846-13 | 2 POUCH in 1 CARTON (68180-846-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.03MG,0.01MG;0.15MG,N/A | ||||
| Approval Date: | Apr 10, 2013 | TE: | AB | RLD: | No | ||||
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