Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011120
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 75MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 150MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 200MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 300MG 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
09/18/1957 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2001 SUPPL-86 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11120S86ltr.pdf
03/27/2000 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

04/22/1998 SUPPL-81 Labeling

Label is not available on this site.

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