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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083312
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/19/1973 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2025 SUPPL-64 Labeling-Container/Carton Labels

Label is not available on this site.
12/27/2023 SUPPL-61 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
11/19/2009 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
03/13/2006 SUPPL-41 Labeling

Label is not available on this site.
06/21/2005 SUPPL-38 Labeling

Label is not available on this site.
04/19/2004 SUPPL-35 Labeling

Label is not available on this site.
04/19/2004 SUPPL-32 Labeling

Label is not available on this site.
11/27/2002 SUPPL-30 Labeling

Label is not available on this site.
11/27/2002 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/12/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
08/09/2001 SUPPL-27 Labeling

Label is not available on this site.
11/19/1999 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
02/11/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
12/27/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
06/16/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
10/30/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
03/12/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
11/09/1990 SUPPL-20 Labeling

Label is not available on this site.
08/23/1990 SUPPL-19 Labeling

Label is not available on this site.
03/30/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription Yes AP 083312 HIKMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 040737 XGEN PHARMS

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 083312 HIKMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 040737 XGEN PHARMS
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