Details for New Drug Application (NDA): 075478
NDA 075478 describes NORTREL 7/7/7, which is a drug marketed by Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the NORTREL 7/7/7 profile page.
The generic ingredient in NORTREL 7/7/7 is ethinyl estradiol; norethindrone. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in NORTREL 7/7/7 is ethinyl estradiol; norethindrone. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 075478
| Tradename: | NORTREL 7/7/7 |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075478
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORTREL 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 075478 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9012 | 0555-9012-58 | 6 POUCH in 1 CARTON (0555-9012-58) / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACK |
| NORTREL 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 075478 | ANDA | Proficient Rx LP | 71205-685 | 71205-685-28 | 1 BLISTER PACK in 1 POUCH (71205-685-28) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-21 | Strength | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | ||||
| Approval Date: | Aug 30, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | ||||
| Approval Date: | Aug 30, 2002 | TE: | AB | RLD: | No | ||||
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