Details for New Drug Application (NDA): 213317
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NDA 213317 describes GEMMILY, which is a drug marketed by Xiromed and is included in one NDA. It is available from two suppliers. Additional details are available on the GEMMILY profile page.
The generic ingredient in GEMMILY is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in GEMMILY is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six 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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