Details for New Drug Application (NDA): 076784
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NDA 076784 describes TRI LO SPRINTEC, which is a drug marketed by Barr Labs Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the TRI LO SPRINTEC profile page.
The generic ingredient in TRI LO SPRINTEC 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 TRI LO SPRINTEC 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 076784
| Tradename: | TRI LO SPRINTEC |
| Applicant: | Barr Labs Inc |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076784
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRI LO SPRINTEC | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 076784 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-2140 | 0093-2140-62 | 3 POUCH in 1 CARTON (0093-2140-62) / 1 BLISTER PACK in 1 POUCH (0093-2140-28) / 1 KIT in 1 BLISTER PACK |
| TRI LO SPRINTEC | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 076784 | ANDA | A-S Medication Solutions | 50090-2326 | 50090-2326-0 | 1 KIT in 1 KIT (50090-2326-0) |
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: | Jun 29, 2009 | TE: | AB | RLD: | No | ||||
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