Details for New Drug Application (NDA): 075840
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NDA 075840 describes CRYSELLE, which is a drug marketed by Duramed Pharms Barr and is included in one NDA. It is available from five suppliers. Additional details are available on the CRYSELLE profile page.
The generic ingredient in CRYSELLE is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
The generic ingredient in CRYSELLE is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075840
| Tradename: | CRYSELLE |
| Applicant: | Duramed Pharms Barr |
| Ingredient: | ethinyl estradiol; norgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075840
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CRYSELLE | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075840 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9049 | 0555-9049-58 | 6 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACK |
| CRYSELLE | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075840 | ANDA | A-S Medication Solutions | 50090-2183 | 50090-2183-0 | 1 KIT in 1 KIT (50090-2183-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-21 | Strength | 0.03MG;0.3MG | ||||
| Approval Date: | Nov 30, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.3MG | ||||
| Approval Date: | Nov 30, 2001 | TE: | AB | RLD: | No | ||||
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