An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 011730
Company: HIKMA

Products on NDA 011730

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011730

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.

Labels for NDA 011730

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

Top