Details for New Drug Application (NDA): 075866
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NDA 075866 describes PORTIA-28, which is a drug marketed by Barr and is included in one NDA. It is available from one supplier. Additional details are available on the PORTIA-28 profile page.
The generic ingredient in PORTIA-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in PORTIA-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 075866
| Tradename: | PORTIA-28 |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075866
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PORTIA-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 075866 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9020 | 0555-9020-58 | 6 POUCH in 1 CARTON (0555-9020-58) / 1 BLISTER PACK in 1 POUCH (0555-9020-79) / 1 KIT in 1 BLISTER PACK |
| PORTIA-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075866 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9020 | 0555-9020-58 | 6 POUCH in 1 CARTON (0555-9020-58) / 1 BLISTER PACK in 1 POUCH (0555-9020-79) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.03MG;0.15MG | ||||
| Approval Date: | May 23, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.15MG | ||||
| Approval Date: | May 23, 2002 | TE: | AB | RLD: | No | ||||
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