Details for New Drug Application (NDA): 202315
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NDA 202315 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 is one drug master file entry 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 202315
| Tradename: | CALCIUM ACETATE |
| Applicant: | Heritage Pharms Inc |
| Ingredient: | calcium acetate |
| Patents: | 0 |
Pharmacology for NDA: 202315
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 202315
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 202315 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-531 | 23155-531-02 | 200 CAPSULE in 1 BOTTLE (23155-531-02) |
| CALCIUM ACETATE | calcium acetate | CAPSULE;ORAL | 202315 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-531 | 23155-531-10 | 1000 CAPSULE in 1 BOTTLE (23155-531-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 667MG | ||||
| Approval Date: | Jun 29, 2015 | TE: | AB | RLD: | No | ||||
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