Details for New Drug Application (NDA): 203135
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NDA 203135 describes CALCIUM ACETATE, which is a drug marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin, Mpp Pharma, 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 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 suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 203135
| Tradename: | CALCIUM ACETATE |
| Applicant: | Invagen Pharms |
| Ingredient: | calcium acetate |
| Patents: | 0 |
Pharmacology for NDA: 203135
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 203135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 203135 | ANDA | American Health Packaging | 60687-589 | 60687-589-01 | 100 BLISTER PACK in 1 CARTON (60687-589-01) / 1 CAPSULE in 1 BLISTER PACK (60687-589-11) |
| CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 203135 | ANDA | American Health Packaging | 60687-589 | 60687-589-65 | 50 BLISTER PACK in 1 CARTON (60687-589-65) / 1 CAPSULE in 1 BLISTER PACK (60687-589-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 667MG | ||||
| Approval Date: | Feb 7, 2013 | TE: | AB | RLD: | No | ||||
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