Details for New Drug Application (NDA): 205762
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NDA 205762 describes TRI-LO-MILI, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from four suppliers. Additional details are available on the TRI-LO-MILI profile page.
The generic ingredient in TRI-LO-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.
The generic ingredient in TRI-LO-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 205762
| Tradename: | TRI-LO-MILI |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205762
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRI-LO-MILI | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 205762 | ANDA | Afaxys Pharma, LLC | 50102-231 | 50102-231-13 | 3 PACKAGE in 1 CARTON (50102-231-13) / 1 BLISTER PACK in 1 PACKAGE (50102-231-11) / 1 KIT in 1 BLISTER PACK (50102-231-01) |
| TRI-LO-MILI | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 205762 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1778 | 53002-1778-1 | 1 KIT in 1 BLISTER PACK (53002-1778-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | ||||
| Approval Date: | Nov 4, 2016 | TE: | AB | RLD: | No | ||||
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