Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078998
Company: ORBION PHARMS
Company: ORBION PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/19/2012 | ORIG-1 | Approval |
Review (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078998Orig1s000OtherActionLtrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078998Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2023 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
07/15/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
07/15/2015 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
IBANDRONATE SODIUM
TABLET;ORAL; EQ 150MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078948 | APOTEX INC |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 204502 | AUROBINDO PHARMA |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078997 | DR REDDYS LABS LTD |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 206887 | MACLEODS PHARMS LTD |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078998 | ORBION PHARMS |
IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 079003 | WATSON LABS TEVA |