Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204222
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/16/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/11/2024 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
IBANDRONATE SODIUM
INJECTABLE;INTRAVENOUS; EQ 3MG BASE/3ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206058 | ACCORD HLTHCARE |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204222 | APOTEX |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205332 | EUGIA PHARMA |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202671 | MYLAN LABS LTD |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202235 | SAGENT PHARMS INC |