Details for New Drug Application (NDA): 213317
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The generic ingredient in GEMMILY is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 213317
Tradename: | GEMMILY |
Applicant: | Xiromed |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 213317
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GEMMILY | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 213317 | ANDA | Northstar Rx LLC | 16714-155 | 16714-155-03 | 3 CARTON in 1 CARTON (16714-155-03) / 1 BLISTER PACK in 1 CARTON (16714-155-01) / 1 KIT in 1 BLISTER PACK |
GEMMILY | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 213317 | ANDA | Xiromed, LLC | 70700-152 | 70700-152-85 | 3 CARTON in 1 CARTON (70700-152-85) / 1 BLISTER PACK in 1 CARTON (70700-152-84) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.02MG;1MG | ||||
Approval Date: | Nov 9, 2020 | TE: | AB | RLD: | No |
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