Details for New Drug Application (NDA): 207081
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NDA 207081 describes KALLIGA, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the KALLIGA profile page.
The generic ingredient in KALLIGA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in KALLIGA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 207081
| Tradename: | KALLIGA |
| Applicant: | Aurobindo Pharma |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207081
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KALLIGA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 207081 | ANDA | Afaxys Pharma, LLC | 50102-254 | 50102-254-23 | 3 POUCH in 1 CARTON (50102-254-23) / 1 BLISTER PACK in 1 POUCH (50102-254-21) / 1 KIT in 1 BLISTER PACK |
| KALLIGA | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 207081 | ANDA | Aurobindo Pharma Limited | 65862-887 | 65862-887-88 | 3 POUCH in 1 CARTON (65862-887-88) / 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-28 | Strength | 0.15MG;0.03MG | ||||
| Approval Date: | May 17, 2017 | TE: | AB | RLD: | No | ||||
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