Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020520
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZANTAC 75 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2019 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s038lbl.pdf | |
| 04/04/2019 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s037lbl.pdf | |
| 07/27/2016 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf | |
| 01/26/2016 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020520Orig1s032LBL.pdf | |
| 11/20/2015 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf | |
| 01/30/2015 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s028lbl_corrected.pdf |