Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017638
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THYPINONE PROTIRELIN 0.5MG/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
11/05/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/25/1991 SUPPL-11 Labeling

Label is not available on this site.

06/07/1991 SUPPL-10 Labeling

Label is not available on this site.

02/14/1990 SUPPL-9 Labeling

Label is not available on this site.

03/24/1986 SUPPL-7 Labeling

Label is not available on this site.

07/16/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1977 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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