Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210428
Company: SPIL
Company: SPIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KAPSPARGO SPRINKLE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
KAPSPARGO SPRINKLE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
KAPSPARGO SPRINKLE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
KAPSPARGO SPRINKLE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | 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 |
---|---|---|---|---|---|---|---|
01/26/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s000lblReplacement.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210428Orig1s000Replacementltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210428Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/14/2023 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210428s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210428Orig1s006ltr.pdf | |
05/14/2018 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/14/2023 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210428s006lbl.pdf | |
05/14/2018 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf | |
05/14/2018 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf | |
01/26/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s000lblReplacement.pdf |