Details for New Drug Application (NDA): 214864
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NDA 214864 describes BETAINE, which is a drug marketed by Eton and Novitium Pharma and is included in two NDAs. It is available from two suppliers. Additional details are available on the BETAINE profile page.
The generic ingredient in BETAINE 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 BETAINE 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 214864
| Tradename: | BETAINE |
| Applicant: | Novitium Pharma |
| Ingredient: | betaine |
| Patents: | 0 |
Pharmacology for NDA: 214864
| Mechanism of Action | Methylating Activity |
Suppliers and Packaging for NDA: 214864
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAINE | betaine | FOR SOLUTION;ORAL | 214864 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0352 | 0713-0352-81 | 180 g in 1 BOTTLE (0713-0352-81) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 1GM/SCOOPFUL | ||||
| Approval Date: | Nov 23, 2021 | TE: | AB | RLD: | No | ||||
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