Details for New Drug Application (NDA): 218036
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NDA 218036 describes LITHIUM CITRATE, which is a drug marketed by Hikma, Pai Holdings Pharm, Rubicon Research, and Sciegen Pharms, and is included in four NDAs. It is available from six suppliers. Additional details are available on the LITHIUM CITRATE profile page.
The generic ingredient in LITHIUM CITRATE is lithium citrate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.
The generic ingredient in LITHIUM CITRATE is lithium citrate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.
Summary for 218036
| Tradename: | LITHIUM CITRATE |
| Applicant: | Rubicon Research |
| Ingredient: | lithium citrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218036
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036 | ANDA | Atlantic Biologicals Corp. | 17856-1172 | 17856-1172-1 | 30 SYRINGE in 1 CASE (17856-1172-1) / 15 mL in 1 SYRINGE |
| LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036 | ANDA | Precision Dose, Inc. | 68094-077 | 68094-077-62 | 3 TRAY in 1 CASE (68094-077-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-077-59) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 300MG CARBONATE/5ML | ||||
| Approval Date: | Aug 14, 2023 | TE: | AA | RLD: | No | ||||
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