Details for New Drug Application (NDA): 090978
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NDA 090978 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 090978
| Tradename: | LANTHANUM CARBONATE |
| Applicant: | Natco Pharma Ltd |
| Ingredient: | lanthanum carbonate |
| Patents: | 0 |
Pharmacology for NDA: 090978
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 090978
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANTHANUM CARBONATE | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 090978 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-819 | 68180-819-42 | 2 BOTTLE in 1 PACKAGE (68180-819-42) / 45 TABLET, CHEWABLE in 1 BOTTLE |
| LANTHANUM CARBONATE | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 090978 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-820 | 68180-820-46 | 6 BOTTLE in 1 PACKAGE (68180-820-46) / 15 TABLET, CHEWABLE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Aug 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 750MG BASE | ||||
| Approval Date: | Aug 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 1GM BASE | ||||
| Approval Date: | Aug 11, 2017 | TE: | AB | RLD: | No | ||||
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