Details for New Drug Application (NDA): 202962
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NDA 202962 describes CHABELINA FE, which is a drug marketed by Novast Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the CHABELINA FE profile page.
The generic ingredient in CHABELINA FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in CHABELINA FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 202962
| Tradename: | CHABELINA FE |
| Applicant: | Novast Labs |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202962
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHABELINA FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 202962 | ANDA | Mayne Pharma Inc. | 51862-896 | 51862-896-01 | 1 BLISTER PACK in 1 PACKET (51862-896-01) / 1 KIT in 1 BLISTER PACK |
| CHABELINA FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 202962 | ANDA | Mayne Pharma Inc. | 51862-896 | 51862-896-02 | 1 BLISTER PACK in 1 CARTON (51862-896-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | ||||
| Approval Date: | Apr 15, 2020 | TE: | AB | RLD: | No | ||||
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