Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088764
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETH VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/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
06/08/2018 SUPPL-87 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-86 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/13/2017 SUPPL-85 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/10/2013 SUPPL-84 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/088764Orig1s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/088764Orig1s084ltr.pdf
05/03/2013 SUPPL-81 Labeling-Package Insert

Label is not available on this site.

03/20/2009 SUPPL-77 Labeling

Label is not available on this site.

08/01/2011 SUPPL-75 Labeling

Label is not available on this site.

10/06/2005 SUPPL-63 Labeling

Label is not available on this site.

05/02/2005 SUPPL-53 Labeling

Label is not available on this site.

06/06/2003 SUPPL-49 Labeling

Label is not available on this site.

07/15/2002 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/2000 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/01/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/02/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 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-34 Labeling

Label is not available on this site.

05/07/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/07/1996 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.

05/30/1996 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.

02/02/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/12/1992 SUPPL-25 Labeling

Label is not available on this site.

01/23/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/08/1991 SUPPL-21 Labeling

Label is not available on this site.

03/29/1990 SUPPL-20 Labeling

Label is not available on this site.

02/07/1990 SUPPL-19 Labeling

Label is not available on this site.

11/06/1989 SUPPL-18 Labeling

Label is not available on this site.

10/03/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/09/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/17/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/19/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/28/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/28/1987 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/10/2013 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/088764Orig1s084lbl.pdf

PROMETH VC W/ CODEINE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040660 VINTAGE
PROMETH VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088764 ACTAVIS MID ATLANTIC
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040674 HI-TECH PHARMA CO
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200963 AMNEAL PHARMS

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