Details for New Drug Application (NDA): 207081
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The generic ingredient in KALLIGA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Seventeen 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 | RPK Pharmaceuticals, Inc. | 53002-2722 | 53002-2722-1 | 1 KIT in 1 BLISTER PACK (53002-2722-1) |
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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