Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070291
Company: BAXTER HLTHCARE
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
07/01/1986 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
11/14/1996 SUPPL-10 Labeling

Label is not available on this site.

02/08/1994 SUPPL-9 Labeling

Label is not available on this site.

09/10/1991 SUPPL-8 Labeling

Label is not available on this site.

03/01/1991 SUPPL-7 Labeling

Label is not available on this site.

01/21/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/21/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/15/1988 SUPPL-3 Labeling

Label is not available on this site.

11/03/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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