Drugs@FDA: FDA-Approved Drugs
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AA | No | Yes |
MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
05/28/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40331ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/22/2024 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-16 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
12/17/2020 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2012 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
09/07/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
06/03/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
MEPERIDINE HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 040331 | EPIC PHARMA LLC |
MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 040893 | GENUS |