Details for New Drug Application (NDA): 090794
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NDA 090794 describes ESTARYLLA, which is a drug marketed by Xiromed and is included in one NDA. It is available from five suppliers. Additional details are available on the ESTARYLLA profile page.
The generic ingredient in 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 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 090794
| Tradename: | ESTARYLLA |
| Applicant: | Xiromed |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090794
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTARYLLA | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090794 | ANDA | Par Pharmaceutical, Inc. | 0254-2029 | 0254-2029-91 | 1 BLISTER PACK in 1 CARTON (0254-2029-91) / 1 KIT in 1 BLISTER PACK |
| ESTARYLLA | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090794 | ANDA | AvKARE | 42291-553 | 42291-553-84 | 3 CARTON in 1 CARTON (42291-553-84) / 1 BLISTER PACK in 1 CARTON (42291-553-28) / 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: | Jan 30, 2013 | TE: | AB | RLD: | No | ||||
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