Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080832
Company: FOSUN PHARMA
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
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
11/03/1972 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
04/07/1997 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

01/10/1995 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

11/05/1990 SUPPL-103 Labeling

Label is not available on this site.

05/21/1990 SUPPL-102 Labeling

Label is not available on this site.

11/02/1989 SUPPL-101 Labeling

Label is not available on this site.

10/18/1989 SUPPL-100 Labeling

Label is not available on this site.

02/02/1987 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

02/02/1987 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

10/01/1985 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

07/08/1985 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

08/22/1984 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

02/07/1984 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

07/12/1983 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

07/12/1983 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

05/23/1983 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

08/05/1982 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

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