Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080727
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Discontinued None No 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
09/27/1972 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
10/29/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/21/1988 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/21/1988 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/21/1988 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/11/1985 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/11/1985 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/04/1982 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

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