Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070698
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLDOPATE HYDROCHLORIDE METHYLDOPATE 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
06/15/1987 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
03/12/1999 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/14/1998 SUPPL-20 Labeling

Label is not available on this site.

03/12/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/11/1996 SUPPL-15 Labeling

Label is not available on this site.

05/10/1995 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/03/1994 SUPPL-13 Labeling

Label is not available on this site.

12/22/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/17/1993 SUPPL-10 Labeling

Label is not available on this site.

04/27/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/09/1991 SUPPL-7 Labeling

Label is not available on this site.

07/15/1988 SUPPL-6 Labeling

Label is not available on this site.

08/17/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/17/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/17/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/06/1987 SUPPL-1 Labeling

Label is not available on this site.

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