Details for New Drug Application (NDA): 203448
✉ Email this page to a colleague
NDA 203448 describes KAITLIB FE, 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 KAITLIB FE profile page.
The generic ingredient in KAITLIB FE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in KAITLIB FE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 203448
| Tradename: | KAITLIB FE |
| Applicant: | Lupin Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203448
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KAITLIB FE | ethinyl estradiol; norethindrone | TABLET, CHEWABLE;ORAL | 203448 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-903 | 68180-903-73 | 3 BLISTER PACK in 1 CARTON (68180-903-73) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (68180-356-74) * 4 TABLET, CHEWABLE in 1 BLISTER PACK (68180-358-74) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 0.025MG;0.8MG | ||||
| Approval Date: | Dec 17, 2015 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
