Details for New Drug Application (NDA): 205449
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The generic ingredient in MILI 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 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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