Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008306
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENERGAN VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No
PHENERGAN W/ CODEINE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
01/21/1952 ORIG-1 Approval Type 4 - New Combination STANDARD

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-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008306Orig1s034ltr.pdf
08/29/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008306Orig1s033ltr.pdf
01/13/2017 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008306Orig1s032ltr.pdf
05/09/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008306Orig1s031ltr.pdf
11/26/2008 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008306s030ltr.pdf
02/23/2001 SUPPL-29 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008306_S029_PHENERGA-CODEINE_AP.pdf
06/23/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/10/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/12/1989 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/12/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/11/1989 SUPPL-19 Labeling

Label is not available on this site.

06/30/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1985 SUPPL-16 Labeling

Label is not available on this site.

07/29/1985 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1986 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1984 SUPPL-12 Labeling

Label is not available on this site.

04/02/1984 SUPPL-11 Efficacy

Label is not available on this site.

04/02/1984 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf
08/29/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s033lbl.pdf
01/13/2017 SUPPL-32 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s032lbl.pdf
01/13/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s032lbl.pdf
05/09/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf
11/26/2008 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf

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