Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088157
Company: HIKMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE INTENSOL CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE;ORAL 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
04/27/1983 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
11/28/2001 SUPPL-9 Labeling

Label is not available on this site.

08/24/1999 SUPPL-8 Labeling

Label is not available on this site.

08/28/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/06/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/03/1992 SUPPL-5 Labeling

Label is not available on this site.

09/13/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/13/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/23/1988 SUPPL-1 Bioequivalence

Label is not available on this site.

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