Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050813
Company: PRAGMA
Company: PRAGMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOXATAG | AMOXICILLIN | 775MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
01/23/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050813lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050813s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813_moxatag_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813s000sumr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2024 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050813s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050813Orig1s010ltr.pdf | |
05/17/2022 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050813s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050813Orig1s009ltr.pdf | |
11/06/2019 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050813s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050813Orig1s008ltr.pdf | |
06/09/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050813s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050813Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/01/2024 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050813s010lbl.pdf | |
05/17/2022 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050813s009lbl.pdf | |
11/06/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050813s008lbl.pdf | |
06/09/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050813s003lbl.pdf |
06/09/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050813s003lbl.pdf |
01/23/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050813lbl.pdf |