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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 two NDAs. It is available from two suppliers. There are two patents protecting this drug. 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: | 2 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 208551
Generic Entry Date for 208551*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | |||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Apr 17, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Sep 8, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT | ||||||||
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