Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088763
Company: ACTAVIS MID ATLANTIC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription AA No 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
10/31/1984 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
06/28/2018 SUPPL-89 Labeling-Package Insert

Label is not available on this site.
06/19/2018 SUPPL-88 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/29/2017 SUPPL-87 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
01/13/2017 SUPPL-86 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
02/19/2014 SUPPL-83 Labeling-Package Insert

Label is not available on this site.
08/27/2009 SUPPL-78 Labeling

Label is not available on this site.
12/19/2008 SUPPL-74 Labeling

Label is not available on this site.
10/06/2005 SUPPL-60 Labeling

Label is not available on this site.
05/02/2005 SUPPL-54 Labeling

Label is not available on this site.
06/06/2003 SUPPL-47 Labeling

Label is not available on this site.
10/03/2001 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.
10/03/2001 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/02/2000 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/01/1998 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.
12/01/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
09/15/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
10/21/1996 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
06/18/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
05/07/1996 SUPPL-33 Labeling

Label is not available on this site.
05/07/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
05/07/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
10/23/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
05/07/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
05/07/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
05/30/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
05/30/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
04/29/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
08/03/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
04/05/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
09/28/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
08/24/1990 SUPPL-19 Labeling

Label is not available on this site.
11/03/1989 SUPPL-18 Labeling

Label is not available on this site.
06/21/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
06/21/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
06/21/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
12/15/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
12/15/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
03/10/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
03/10/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
02/18/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
10/13/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
02/18/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
08/14/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

SYRUP;ORAL; 10MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088763 ACTAVIS MID ATLANTIC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200894 AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040151 HI TECH PHARMA
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 090180 NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200386 TRIS PHARMA INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088875 WOCKHARDT BIO AG
PROMETHAZINE WITH CODEINE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040650 VINTAGE

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