Details for New Drug Application (NDA): 206868
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NDA 206868 describes LANTHANUM CARBONATE, which is a drug marketed by Alkem Labs Ltd, Barr, Invagen Pharms, and Natco Pharma Ltd, and is included in four NDAs. It is available from five suppliers. Additional details are available on the LANTHANUM CARBONATE profile page.
The generic ingredient in LANTHANUM CARBONATE is lanthanum carbonate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
The generic ingredient in LANTHANUM CARBONATE is lanthanum carbonate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
Summary for 206868
| Tradename: | LANTHANUM CARBONATE |
| Applicant: | Invagen Pharms |
| Ingredient: | lanthanum carbonate |
| Patents: | 0 |
Pharmacology for NDA: 206868
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 206868
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANTHANUM CARBONATE | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 206868 | ANDA | Cipla USA Inc. | 69097-934 | 69097-934-98 | 2 BOTTLE in 1 PACKAGE (69097-934-98) / 45 TABLET, CHEWABLE in 1 BOTTLE (69097-934-57) |
| LANTHANUM CARBONATE | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 206868 | ANDA | Cipla USA Inc. | 69097-935 | 69097-935-98 | 6 BOTTLE in 1 PACKAGE (69097-935-98) / 15 TABLET, CHEWABLE in 1 BOTTLE (69097-935-89) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Jan 24, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 750MG BASE | ||||
| Approval Date: | Jan 24, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 1GM BASE | ||||
| Approval Date: | Jan 24, 2022 | TE: | AB | RLD: | No | ||||
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