Details for New Drug Application (NDA): 090538
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NDA 090538 describes BRIELLYN, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the BRIELLYN profile page.
The generic ingredient in BRIELLYN 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 BRIELLYN 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 090538
| Tradename: | BRIELLYN |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090538
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIELLYN | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090538 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-316 | 68462-316-29 | 3 BLISTER PACK in 1 CARTON (68462-316-29) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.4MG | ||||
| Approval Date: | Mar 22, 2011 | TE: | AB | RLD: | No | ||||
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