Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008381
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PLAIN PROMETHAZINE HYDROCHLORIDE 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No
PROMETHAZINE HYDROCHLORIDE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
04/11/1952 ORIG-1 Approval Type 2 - New Active Ingredient 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
11/10/2008 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008381s030ltr.pdf
04/02/2008 SUPPL-28 Manufacturing (CMC) 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
06/27/2003 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf
06/27/2003 SUPPL-26 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf
05/06/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

02/06/1992 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

12/13/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1988 SUPPL-18 Labeling

Label is not available on this site.

03/02/1987 SUPPL-14 Labeling

Label is not available on this site.

09/08/1986 SUPPL-13 Labeling

Label is not available on this site.

11/04/1985 SUPPL-12 Labeling

Label is not available on this site.

07/27/1985 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1984 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

04/18/1984 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/18/1984 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/10/2008 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf
04/02/2008 SUPPL-28 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf

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