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Details for New Drug Application (NDA): 208551
NDA 208551 describes TRIFERIC , which is a drug marketed by Rockwell Medical Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the TRIFERIC profile page.
The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ferric pyrophosphate citrate profile page.
The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ferric pyrophosphate citrate profile page.
Summary for 208551
| Tradename: | TRIFERIC |
| Applicant: | Rockwell Medical Inc |
| Ingredient: | ferric pyrophosphate citrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208551
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 208551
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIFERIC | ferric pyrophosphate citrate | FOR SOLUTION;INTRAVENOUS | 208551 | NDA | Rockwell Medical, Inc | 57278-315 | 57278-315-02 | 100 PACKET in 1 CARTON (57278-315-02) > 1 POWDER in 1 PACKET |
| TRIFERIC | ferric pyrophosphate citrate | FOR SOLUTION;INTRAVENOUS | 208551 | NDA | Ropack Inc. | 64811-315 | 64811-315-02 | 100 PACKET in 1 CARTON (64811-315-02) > 272 mg in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INTRAVENOUS | Strength | 272MG IRON/PACKET | ||||
| Approval Date: | Apr 25, 2016 | TE: | RLD: | Yes | |||||
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