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, and Sciegen Pharms Inc, and is included in four NDAs. It is available from three suppliers. Additional details are available on the LITHIUM CITRATE profile page.
The generic ingredient in LITHIUM CITRATE is lithium citrate. There are fifteen drug master file entries for this compound. Three 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 are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.
Summary for 218036
| Tradename: | LITHIUM CITRATE |
| Applicant: | Rubicon |
| 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 | REMEDYREPACK INC. | 70518-4227 | 70518-4227-0 | 10 CUP in 1 BOX (70518-4227-0) / 5 mL in 1 CUP (70518-4227-1) |
| LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036 | ANDA | REMEDYREPACK INC. | 70518-4227 | 70518-4227-2 | 10 CUP, UNIT-DOSE in 1 BOX (70518-4227-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-4227-3) |
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 | ||||
| Regulatory Exclusivity Expiration: | Mar 18, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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