Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080738
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/24/1972 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/1999 SUPPL-88 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

05/21/1999 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

09/08/1998 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

09/13/1991 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

03/10/1988 SUPPL-75 Labeling

Label is not available on this site.

04/17/1986 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

03/28/1986 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

03/28/1986 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

03/08/1983 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

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