Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011265
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
12/03/1957 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
09/16/2009 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011265s031ltr.pdf
04/02/2008 SUPPL-29 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf
01/16/2004 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11265slr028ltr.pdf
02/23/2001 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/011265_S027_PHERGAN_AP.pdf
05/06/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/27/1996 SUPPL-24 Labeling

Label is not available on this site.

03/30/1992 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/16/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1988 SUPPL-19 Efficacy-Rx To OTC Switch

Label is not available on this site.

09/16/1985 SUPPL-18 Labeling

Label is not available on this site.

07/31/1985 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1984 SUPPL-14 Labeling

Label is not available on this site.

04/02/1984 SUPPL-13 Efficacy

Label is not available on this site.

04/02/1984 SUPPL-12 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
04/02/2008 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf
04/02/2008 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf

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