Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011689
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENERGAN PROMETHAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No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
04/27/1960 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
08/04/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/08/2004 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11689s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11689s024ltr.pdf
09/12/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/26/2002 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
12/26/2002 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
12/26/2002 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
08/01/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/26/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
07/01/1994 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/28/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1988 SUPPL-9 Labeling

Label is not available on this site.

05/29/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11689s024lbl.pdf

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