Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 003977
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEELIN ESTRONE 1MG/ML INJECTABLE;INJECTION Discontinued None No No
THEELIN ESTRONE 2MG/ML INJECTABLE;INJECTION Discontinued None No No
THEELIN ESTRONE 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
06/12/1941 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/1988 SUPPL-13 Labeling

Label is not available on this site.

05/17/1988 SUPPL-12 Labeling

Label is not available on this site.

12/29/1987 SUPPL-10 Labeling

Label is not available on this site.

04/07/1987 SUPPL-8 Labeling

Label is not available on this site.

09/29/1986 SUPPL-7 Labeling

Label is not available on this site.

03/27/1996 SUPPL-6 Labeling

Label is not available on this site.

10/20/1978 SUPPL-4 Labeling

Label is not available on this site.

03/27/1996 SUPPL-3 Labeling

Label is not available on this site.

03/27/1996 SUPPL-2 Labeling

Label is not available on this site.

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