Details for New Drug Application (NDA): 072695
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NDA 072695 describes NORTREL 0.5/35-28, 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 0.5/35-28 profile page.
The generic ingredient in NORTREL 0.5/35-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in NORTREL 0.5/35-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 072695
| Tradename: | NORTREL 0.5/35-28 |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 072695
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORTREL 0.5/35-28 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 072695 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9008 | 0555-9008-67 | 3 POUCH in 1 CARTON (0555-9008-67) / 1 BLISTER PACK in 1 POUCH (0555-9008-79) / 1 KIT in 1 BLISTER PACK |
| NORTREL 0.5/35-28 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 072695 | ANDA | A-S Medication Solutions | 50090-3229 | 50090-3229-0 | 1 KIT in 1 KIT (50090-3229-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.5MG | ||||
| Approval Date: | Feb 28, 1992 | TE: | AB | RLD: | No | ||||
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