Sodium ferric gluconate complex Injectable Solution
- Brand(s)
- Ferrlecit, Nulecit
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sanofi-Aventis U.S. Llc (2015-04-13)
- Oldest Current Product
- 1999-02-18
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\SODIUM FERRIC GLUCONATE COMPLEX
- FDAOB
- INJECTION\INJECTION\SODIUM FERRIC GLUCONATE COMPLEX\rdfq
- SPL Active
- INTRAVENOUS\INJECTION\SODIUM FERRIC GLUCONATE COMPLEX
- SPL Moiety
- INTRAVENOUS\INJECTION\FERRIC CATION
INTRAVENOUS\INJECTION\FERRIC CATION: IRON
INTRAVENOUS\INJECTION\IRON
product(s) by strength(s)
sodium ferric gluconate complex 12.5 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000242791 | Ferrlecit | NDA | Sanofi-Aventis U.S. Llc | 1999-02-18 | 2014-10-31 | SODIUM FERRIC GLUCONATE COMPLEX | INTRAVENOUS | INJECTION | NDA020955 | 1fe028ff-42ac-4329-b1a5-a9dadfcb79f6 |
| 2 | 000242794 | Ferrlecit | NDA | Sanofi-Aventis U.S. Llc | 2014-07-07 | SODIUM FERRIC GLUCONATE COMPLEX | INTRAVENOUS | INJECTION | NDA020955 | b25b34ab-9cf1-4a2b-bdf2-5eaf66625999 |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439570 | ANDA | West-Ward Pharmaceutical Corp | 2011-03-31 | SODIUM FERRIC GLUCONATE COMPLEX | INTRAVENOUS | INJECTION | ANDA078215 | 218d1b8d-b24f-4f77-b588-97c7dd1c2eec | |
| 2 | 005910149 | ANDA | Watson Laboratories, Inc. | 2011-03-31 | SODIUM FERRIC GLUCONATE COMPLEX | INTRAVENOUS | INJECTION | ANDA078215 | 2b28ca1b-673e-491b-9421-678c999261b0 | |
| 3 | 005912508 | ANDA | Watson Laboratories, Inc. | 2012-08-23 | SODIUM FERRIC GLUCONATE COMPLEX | INTRAVENOUS | INJECTION | ANDA078215 | fc374c01-f3ed-4920-920b-b19f20fd20a9 | |
| 4 | 525440149 | Nulecit | ANDA | Actavis Pharma, Inc. | 2011-03-31 | SODIUM FERRIC GLUCONATE COMPLEX | INTRAVENOUS | INJECTION | ANDA078215 | 72153161-a533-4e90-b9b8-54090b8816be |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA078215 | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE | EUROHEALTH INTERNATIONAL SARL | 2011-03-31 | ANDA078215_001 |
| 2 | NDA020955 | FERRLECIT | SANOFI AVENTIS US LLC | 1999-02-18 | NDA020955_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA078215_001 | RX | SODIUM FERRIC GLUCONATE COMPLEX (62.5MG/5ML) | INJECTION | False | AB | 2011-03-31 | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE |
| 2 | NDA020955_001 | RX | SODIUM FERRIC GLUCONATE COMPLEX (62.5MG/5ML) | INJECTION | True | AB | 1999-02-18 | FERRLECIT |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1fe028ff-42ac-4329-b1a5-a9dadfcb79f6 (view SPL) | These highlights do not include all the information needed to use Ferrlecit safely and effectively. See full prescribing information for Ferrlecit. Ferrlecit (sodium ferric gluconate complex in sucrose injection), For intravenous (IV) use Initial U.S. Approval: 1999 | prescription | Human Prescription | Sanofi-Aventis U.S. Llc | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-04-13 | 3 | 000242791, 000242792 |
| 2 | 218d1b8d-b24f-4f77-b588-97c7dd1c2eec (view SPL) | These highlights do not include all the information needed to usesodium ferric gluconate complex in sucrose injection safely and effectively. See full prescribing information for sodium ferric gluconate complex in sucrose injection. Sodium ferric gluconate complex in sucrose injection, for intravenous (IV)use Initial U.S. Approval: 1999 | prescription | Human Prescription | West-Ward Pharmaceutical Corp | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-11-21 | 1 | 001439570 |
| 3 | 2b28ca1b-673e-491b-9421-678c999261b0 (view SPL) | These highlights do not include all the information needed to use sodium ferric gluconate complex in sucrose injection safely and effectively. See full prescribing information for sodium ferric gluconate complex in sucrose injection . S odium ferric gluconate complex in sucrose injection, for intravenous (IV) use Initial U.S. Approval: 1999 | prescription | Human Prescription | Watson Laboratories, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2011-10-31 | 6 | 005910149 |
| 4 | 72153161-a533-4e90-b9b8-54090b8816be (view SPL) | Nulecit | prescription | Human Prescription | Actavis Pharma, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2011-04-01 | 4 | 525440149 |
| 5 | b25b34ab-9cf1-4a2b-bdf2-5eaf66625999 (view SPL) | These highlights do not include all the information needed to use Ferrlecit safely and effectively. See full prescribing information for Ferrlecit. Ferrlecit (sodium ferric gluconate complex in sucrose injection), For intravenous (IV) use Initial U.S. Approval: 1999 | prescription | Human Prescription | Sanofi-Aventis U.S. Llc | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-05-23 | 1 | 000242794 |
| 6 | fc374c01-f3ed-4920-920b-b19f20fd20a9 (view SPL) | These highlights do not include all the information needed to usesodium ferric gluconate complex in sucrose injection safely and effectively. See full prescribing information for sodium ferric gluconate complex in sucrose injection. Sodium ferric gluconate complex in sucrose injection, for intravenous (IV) use Initial U.S. Approval: 1999 | prescription | Human Prescription | Watson Laboratories, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2012-03-01 | 8 | 005912508 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII