Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080873
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Discontinued None No No
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Discontinued None No No
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION 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
01/29/1974 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
03/22/1999 SUPPL-218 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-216 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-215 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/15/1997 SUPPL-214 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-213 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/11/1989 SUPPL-212 Bioequivalence

Label is not available on this site.

11/04/1993 SUPPL-211 Labeling

Label is not available on this site.

12/23/1988 SUPPL-210 Manufacturing (CMC)

Label is not available on this site.

05/12/1989 SUPPL-206 Labeling

Label is not available on this site.

01/12/1988 SUPPL-204 Manufacturing (CMC)

Label is not available on this site.

01/12/1988 SUPPL-203 Manufacturing (CMC)

Label is not available on this site.

10/02/1986 SUPPL-202 Manufacturing (CMC)

Label is not available on this site.

07/01/1985 SUPPL-201 Manufacturing (CMC)

Label is not available on this site.

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