Details for New Drug Application (NDA): 090793
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NDA 090793 describes TRI-ESTARYLLA, which is a drug marketed by Xiromed and is included in one NDA. It is available from three suppliers. Additional details are available on the TRI-ESTARYLLA profile page.
The generic ingredient in TRI-ESTARYLLA 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 TRI-ESTARYLLA 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 090793
| Tradename: | TRI-ESTARYLLA |
| Applicant: | Xiromed |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090793
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRI-ESTARYLLA | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090793 | ANDA | AvKARE | 42291-590 | 42291-590-84 | 1 CARTON in 1 CARTON (42291-590-84) / 3 BLISTER PACK in 1 CARTON (42291-590-28) / 1 KIT in 1 BLISTER PACK |
| TRI-ESTARYLLA | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090793 | ANDA | Bryant Ranch Prepack | 63629-2350 | 63629-2350-1 | 3 BLISTER PACK in 1 CARTON (63629-2350-1) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | ||||
| Approval Date: | Jan 30, 2013 | TE: | AB | RLD: | No | ||||
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