Details for New Drug Application (NDA): 090977
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The generic ingredient in LANTHANUM CARBONATE is lanthanum carbonate. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
Summary for 090977
Tradename: | LANTHANUM CARBONATE |
Applicant: | Barr |
Ingredient: | lanthanum carbonate |
Patents: | 0 |
Pharmacology for NDA: 090977
Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 090977
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LANTHANUM CARBONATE | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 090977 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5938 | 0093-5938-98 | 2 BOTTLE in 1 CARTON (0093-5938-98) / 45 TABLET, CHEWABLE in 1 BOTTLE (0093-5938-54) |
LANTHANUM CARBONATE | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 090977 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5939 | 0093-5939-98 | 6 BOTTLE in 1 CARTON (0093-5939-98) / 15 TABLET, CHEWABLE in 1 BOTTLE (0093-5939-85) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Jan 27, 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 27, 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 27, 2022 | TE: | AB | RLD: | No |
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