Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075030
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEMOLINE PEMOLINE 37.5MG TABLET;ORAL Discontinued None No No
PEMOLINE PEMOLINE 75MG TABLET;ORAL Discontinued None No No
PEMOLINE PEMOLINE 18.75MG TABLET;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
01/29/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75030ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/07/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

02/22/2000 SUPPL-10 Labeling

Label is not available on this site.

02/22/2000 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/2000 SUPPL-8 Manufacturing (CMC)-New Strength

Label is not available on this site.

08/13/1999 SUPPL-7 Labeling

Label is not available on this site.

06/11/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/11/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/11/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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