Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040191
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
12/17/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40191_Meperidine%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40191ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040191_meperidine_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/15/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2023 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/13/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-14 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
12/13/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
01/06/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
10/18/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
07/01/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/06/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
07/07/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/17/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40191_Meperidine%20Hydrochloride_Prntlbl.pdf |