Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212319
Company: RAFA LABS LTD
Company: RAFA LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATROPINE (AUTOINJECTOR) | ATROPINE | EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) | SOLUTION;INTRAMUSCULAR | 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 |
---|---|---|---|---|---|---|---|
07/09/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/212319s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/212319Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/27/2023 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212319Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212319Orig1s007ltr.pdf | |
07/09/2019 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212319s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212319Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/27/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212319Orig1s007lbl.pdf | |
02/27/2023 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212319Orig1s007lbl.pdf | |
07/09/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212319s002lbl.pdf | |
07/09/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/212319s000lbl.pdf |