Iron-Dextran Complex Injectable Solution
- Brand(s)
- Dexferrum, InFed
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Actavis Pharma, Inc. (2014-07-10)
- Oldest Current Product
- 1974-04-29
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\IRON-DEXTRAN COMPLEX
- FDAOB
- INJECTION\INJECTION\IRON DEXTRAN\rdfq
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\IRON DEXTRAN
INTRAMUSCULAR\INJECTION\IRON DEXTRAN
INTRAVENOUS\INJECTION, SOLUTION\IRON DEXTRAN - SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\IRON
INTRAMUSCULAR\INJECTION\FERRIC CATION
INTRAVENOUS\INJECTION, SOLUTION\FERRIC CATION
product(s) by strength(s)
iron-dextran complex 50 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 005170134 | Dexferrum | NDA | American Regent, Inc. | 1998-10-01 | IRON DEXTRAN | INTRAVENOUS | INJECTION, SOLUTION | NDA040024 | 77f5ae2a-8cd3-4f01-bddd-8158f932c8db |
| 2 | 525440931 | InFed | NDA | Actavis Pharma, Inc. | 1974-04-29 | IRON DEXTRAN | INTRAMUSCULAR | INJECTION | NDA017441 | abacb7fa-2fc2-471e-9200-944eeac8ca2a |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840931 | InFed | NDA | General Injecatables & Vaccines, Inc | 2010-09-01 | IRON DEXTRAN | INTRAMUSCULAR | INJECTION, SOLUTION | 525440931 | NDA017441 | 06e33e48-0c96-4f34-bbfb-39d29ea97dde |
application(s)
| # | id | title | deprecated | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA010787 | IRON DEXTRAN | True | SANOFI AVENTIS US LLC | NDA010787_002 | ||
| 2 | NDA017441 | INFED | ACTAVIS LABORATORIES UT INC | NDA017441_001 | |||
| 3 | NDA017807 | PROFERDEX | NEW RIVER PHARMACEUTICALS INC | NDA017807_001 | |||
| 4 | NDA040024 | DEXFERRUM | LUITPOLD PHARMACEUTICALS INC | 1996-02-23 | p5624668 | NDA040024_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA010787_002 | discontinued | IRON DEXTRAN (EQ 50MG IRON/ML) | INJECTION | False | IRON DEXTRAN | ||
| 2 | NDA017441_001 | RX | IRON DEXTRAN (EQ 50MG IRON/ML) | INJECTION | True | BP | INFED | |
| 3 | NDA017807_001 | RX | IRON DEXTRAN (EQ 50MG IRON/ML) | INJECTION | False | BP | PROFERDEX | |
| 4 | NDA040024_001 | RX | IRON DEXTRAN (EQ 50MG IRON/ML) | INJECTION | False | BP | 1996-02-23 | DEXFERRUM |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5624668 (view patent) | 2015-09-29 | NDA040024 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 06e33e48-0c96-4f34-bbfb-39d29ea97dde (view SPL) | Infed (Iron Dextran) 20 mg/mL Injection, USP 2 mL Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2011-06-13 | 3 | 525840931 | |
| 2 | 77f5ae2a-8cd3-4f01-bddd-8158f932c8db (view SPL) | DEXFERRUM (IRON DEXTRAN INJECTION, USP) | prescription | Human Prescription | American Regent, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2014-04-02 | 6 | 005170134, 005170234 |
| 3 | abacb7fa-2fc2-471e-9200-944eeac8ca2a (view SPL) | INFeD(IRON DEXTRAN INJECTION USP)Rx onlyRevised: January 2014255769 | prescription | Human Prescription | Actavis Pharma, Inc. | 2014-07-10 | 5 | 525440931 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII