Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215133
Company: ALMATICA
Company: ALMATICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | None | Yes | Yes |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
10/04/2021 | ORIG-2 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215133Orig1s000, 215133Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215133Orig1s000,215133Orig2TOC.cfm |
10/04/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215133s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215133Orig1s000, 215133Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215133Orig1s000,215133Orig2TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215133s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215428Orig1s002,215133Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215133s001lbl.pdf | |
08/18/2023 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215133s001lbl.pdf | |
10/04/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215133s000lbl.pdf |