Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010926
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENERGAN PROMETHAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No
PHENERGAN PROMETHAZINE HYDROCHLORIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No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
05/05/1958 ORIG-1 Approval Type 3 - New Dosage Form 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-31 Manufacturing (CMC)

Label is not available on this site.

11/08/2004 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10926s030ltr.pdf
09/12/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/26/2002 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
12/26/2002 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
12/26/2002 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
07/27/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/22/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/26/2002 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
07/01/1994 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/28/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1988 SUPPL-10 Labeling

Label is not available on this site.

05/29/1986 SUPPL-7 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-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf

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