Details for New Drug Application (NDA): 202980
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NDA 202980 describes TURQOZ, 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 TURQOZ profile page.
The generic ingredient in TURQOZ is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
The generic ingredient in TURQOZ is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 202980
| Tradename: | TURQOZ |
| Applicant: | Lupin Ltd |
| Ingredient: | ethinyl estradiol; norgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202980
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TURQOZ | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 202980 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-895 | 68180-895-13 | 3 BLISTER PACK in 1 CARTON (68180-895-13) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.3MG | ||||
| Approval Date: | Jul 31, 2023 | TE: | AB | RLD: | No | ||||
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