Details for New Drug Application (NDA): 020576
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NDA 020576 describes CYSTADANE, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTADANE profile page.
The generic ingredient in CYSTADANE is betaine. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the betaine profile page.
The generic ingredient in CYSTADANE is betaine. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the betaine profile page.
Summary for 020576
| Tradename: | CYSTADANE |
| Applicant: | Recordati Rare |
| Ingredient: | betaine |
| Patents: | 0 |
Pharmacology for NDA: 020576
| Mechanism of Action | Methylating Activity |
Suppliers and Packaging for NDA: 020576
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYSTADANE | betaine | FOR SOLUTION;ORAL | 020576 | NDA | Recordati Rare Diseases | 52276-400 | 52276-400-01 | 180 g in 1 BOTTLE (52276-400-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 1GM/SCOOPFUL | ||||
| Approval Date: | Oct 25, 1996 | TE: | AB | RLD: | Yes | ||||
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