DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203135
NDA 203135 describes CALCIUM ACETATE, which is a drug marketed by Amneal Pharms, Chartwell Rx, Eci Pharms Llc, Heritage Pharms Inc, Invagen Pharms, Lupin Ltd, Nostrum Labs Inc, West-ward Pharms Int, and Paddock Llc, and is included in twelve NDAs. It is available from twenty-seven 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 seventy-five drug master file entries for this compound. Thirty-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 seventy-five drug master file entries for this compound. Thirty-two 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 |
| Therapeutic Class: | Genitourinary Agents Therapeutic Nutrients/Minerals/Electrolytes |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203135
| Ingredient-type | Calcium Cations, Divalent |
| 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 | Atlantic Biologicals Corps | 17856-0377 | N | 17856-0377-2 |
| CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 203135 | ANDA | Camber Pharmaceuticals, Inc. | 31722-377 | E | 31722-377-02 |
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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