Details for New Drug Application (NDA): 205449
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NDA 205449 describes MILI, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the MILI profile page.
The generic ingredient in MILI is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
The generic ingredient in MILI is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 205449
| Tradename: | MILI |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MILI | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 205449 | ANDA | Afaxys Pharma, LLC | 50102-235 | 50102-235-11 | 1 BLISTER PACK in 1 CARTON (50102-235-11) / 1 KIT in 1 BLISTER PACK |
| MILI | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 205449 | ANDA | Afaxys Pharma, LLC | 50102-235 | 50102-235-13 | 3 BLISTER PACK in 1 CARTON (50102-235-13) / 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: | Jul 7, 2016 | TE: | AB | RLD: | No | ||||
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