Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212516
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DRIZALMA SPRINKLE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
DRIZALMA SPRINKLE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
DRIZALMA SPRINKLE | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
DRIZALMA SPRINKLE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;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 |
---|---|---|---|---|---|---|---|
07/19/2019 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212516s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212516Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212516Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212516s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212516Orig1s005ltr.pdf | |
07/23/2021 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212516s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212516Orig1s002ltr.pdf | |
06/24/2020 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212516s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212516Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212516s005lbl.pdf | |
08/18/2023 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212516s005lbl.pdf | |
07/23/2021 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212516s002lbl.pdf | |
06/24/2020 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212516s001lbl.pdf | |
07/19/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212516s000lbl.pdf |