Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085075
Company: FLEMING PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AEROLATE III THEOPHYLLINE 65MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
AEROLATE JR THEOPHYLLINE 130MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
AEROLATE SR THEOPHYLLINE 260MG CAPSULE, EXTENDED RELEASE;ORAL 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
11/24/1986 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
10/18/1990 SUPPL-4 Labeling

Label is not available on this site.

10/13/1989 SUPPL-2 Labeling

Label is not available on this site.

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