Details for New Drug Application (NDA): 075804
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NDA 075804 describes SPRINTEC, which is a drug marketed by Barr and is included in one NDA. It is available from five suppliers. Additional details are available on the SPRINTEC profile page.
The generic ingredient in 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 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 075804
| Tradename: | SPRINTEC |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075804
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPRINTEC | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 075804 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9016 | 0555-9016-58 | 6 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
| SPRINTEC | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 075804 | ANDA | Proficient Rx LP | 63187-911 | 63187-911-28 | 1 BLISTER PACK in 1 POUCH (63187-911-28) / 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: | Sep 25, 2002 | TE: | AB | RLD: | No | ||||
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