Details for New Drug Application (NDA): 091453
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NDA 091453 describes LARIN FE 1.5/30, which is a drug marketed by Novast Labs and is included in one NDA. It is available from four suppliers. Additional details are available on the LARIN FE 1.5/30 profile page.
The generic ingredient in LARIN FE 1.5/30 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.
The generic ingredient in LARIN FE 1.5/30 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 091453
| Tradename: | LARIN FE 1.5/30 |
| Applicant: | Novast Labs |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091453
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LARIN FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 091453 | ANDA | Northstar Rx LLC | 16714-405 | 16714-405-01 | 1 BLISTER PACK in 1 PACKET (16714-405-01) / 1 KIT in 1 BLISTER PACK |
| LARIN FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 091453 | ANDA | Northstar Rx LLC | 16714-405 | 16714-405-02 | 1 BLISTER PACK in 1 CARTON (16714-405-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;1.5MG | ||||
| Approval Date: | Aug 23, 2013 | TE: | AB | RLD: | No | ||||
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