Details for New Drug Application (NDA): 090523
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NDA 090523 describes MONO-LINYAH, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the MONO-LINYAH profile page.
The generic ingredient in MONO-LINYAH is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
The generic ingredient in MONO-LINYAH is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 090523
| Tradename: | MONO-LINYAH |
| Applicant: | Novast Labs Ltd |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090523
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MONO-LINYAH | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090523 | ANDA | Northstar Rx LLC | 16714-360 | 16714-360-01 | 1 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACK |
| MONO-LINYAH | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090523 | ANDA | Northstar Rx LLC | 16714-360 | 16714-360-02 | 1 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.25MG | ||||
| Approval Date: | May 23, 2012 | TE: | AB | RLD: | No | ||||
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