Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084506
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 25MG 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
12/19/1974 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
12/01/1998 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/21/1988 SUPPL-52 Labeling

Label is not available on this site.

03/20/1987 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/31/1983 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

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