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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007935
Company: DELCOR ASSET CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENERGAN PROMETHAZINE HYDROCHLORIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
PHENERGAN PROMETHAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
PHENERGAN PROMETHAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
03/29/1951 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
11/08/2004 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07935s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/07935s030ltr.pdf
03/13/2009 SUPPL-29 Labeling

Label is not available on this site.
12/26/2002 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf
03/13/2009 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf
03/13/2009 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf
03/30/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
03/13/2009 SUPPL-23 Labeling

Label is not available on this site.
06/30/1988 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
11/21/1989 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/07/1988 SUPPL-20 Labeling

Label is not available on this site.
01/22/1988 SUPPL-19 Labeling

Label is not available on this site.
05/31/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
12/11/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/19/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/2009 SUPPL-13 Labeling

Label is not available on this site.
05/29/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/2009 SUPPL-9 Labeling

Label is not available on this site.
03/13/2009 SUPPL-7 Labeling

Label is not available on this site.
03/13/2009 SUPPL-6 Labeling

Label is not available on this site.
03/13/2009 SUPPL-4 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/08/2004 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07935s030lbl.pdf
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