Details for New Drug Application (NDA): 075808
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NDA 075808 describes TRI-SPRINTEC, which is a drug marketed by Barr and is included in one NDA. It is available from four suppliers. Additional details are available on the TRI-SPRINTEC profile page.
The generic ingredient in TRI-SPRINTEC 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-SPRINTEC 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 075808
| Tradename: | TRI-SPRINTEC |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075808
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRI-SPRINTEC | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 075808 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9018 | 0555-9018-58 | 6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
| TRI-SPRINTEC | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 075808 | ANDA | Proficient Rx LP | 63187-458 | 63187-458-28 | 6 POUCH in 1 CARTON (63187-458-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | ||||
| Approval Date: | Dec 29, 2003 | TE: | AB | RLD: | No | ||||
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