Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020951
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAGAMET HB 200 | CIMETIDINE | 200MG/20ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
07/09/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20951lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20951ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020951A_Tagament.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/28/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/24/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/14/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/09/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20951lbl.pdf |