Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEPERGAN | MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 25MG/ML;25MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
11/13/1961 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011730s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011730Orig1s033ltr.pdf | |
10/07/2019 | SUPPL-32 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011730Orig1s032ltr.pdf |
12/16/2016 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011730s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011730Orig1s031ltr.pdf | |
11/29/1995 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/28/1994 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/25/1993 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/13/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/19/1999 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
02/17/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/06/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/06/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/06/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/20/1981 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/23/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
10/05/1978 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011730s033lbl.pdf | |
12/16/2016 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011730s031lbl.pdf | |
12/16/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011730s031lbl.pdf |