Details for New Drug Application (NDA): 091312
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NDA 091312 describes CALCIUM ACETATE, which is a drug marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Nostrum Labs Inc, Square Pharms, Suven Pharms, Chartwell Molecular, and Padagis Us, and is included in fourteen NDAs. It is available from twenty suppliers. Additional details are available on the CALCIUM ACETATE profile page.
The generic ingredient in CALCIUM ACETATE is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
The generic ingredient in CALCIUM ACETATE is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 091312
| Tradename: | CALCIUM ACETATE |
| Applicant: | Chartwell Rx |
| Ingredient: | calcium acetate |
| Patents: | 0 |
Pharmacology for NDA: 091312
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 091312
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 091312 | ANDA | Chartwell RX, LLC. | 62135-191 | 62135-191-22 | 200 CAPSULE in 1 BOTTLE (62135-191-22) |
| CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 091312 | ANDA | Chartwell RX, LLC. | 62135-191 | 62135-191-30 | 30 CAPSULE in 1 BOTTLE (62135-191-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 667MG | ||||
| Approval Date: | Jun 1, 2012 | TE: | AB | RLD: | No | ||||
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