Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077167
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIDANOSINE | DIDANOSINE | 200MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
DIDANOSINE | DIDANOSINE | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
DIDANOSINE | DIDANOSINE | 400MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
12/03/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77167ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/10/2012 | SUPPL-7 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/22/2010 | SUPPL-5 | REMS-Proposal, Labeling-Package Insert |
Label is not available on this site. |
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01/29/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |