Details for New Drug Application (NDA): 076785
✉ Email this page to a colleague
NDA 076785 describes KELNOR, 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 KELNOR profile page.
The generic ingredient in KELNOR is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
The generic ingredient in KELNOR is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
Summary for 076785
| Tradename: | KELNOR |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; ethynodiol diacetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076785
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KELNOR | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 076785 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9064 | 0555-9064-58 | 6 POUCH in 1 CARTON (0555-9064-58) / 1 BLISTER PACK in 1 POUCH (0555-9064-79) / 1 KIT in 1 BLISTER PACK |
| KELNOR | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 076785 | ANDA | A-S Medication Solutions | 50090-2191 | 50090-2191-0 | 1 KIT in 1 KIT (50090-2191-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;1MG | ||||
| Approval Date: | May 23, 2005 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
