Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011730
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
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
12/16/2016 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

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