Drugs@FDA: FDA-Approved Drugs
Company: MEDTECH PRODUCTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAGAMET HB | CIMETIDINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TAGAMET HB | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/19/1995 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | 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 |
---|---|---|---|---|---|
05/24/2022 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020238Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020238Orig1s026ltr.pdf | |
03/15/2021 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020238Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020238Orig1s025ltr.pdf | |
04/13/2020 | SUPPL-24 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020238Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020238Orig1s024ltr.pdf | |
03/26/2019 | SUPPL-23 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020238Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020238Orig1s023ltr.pdf | |
09/26/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/06/2008 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020238s017ltr.pdf |
10/04/2006 | SUPPL-15 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020238s015LTR.pdf |
05/10/2005 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020238s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020238s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020238_s013_TAGAMET HB.pdf | |
08/11/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/14/1999 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/06/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/10/1998 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/05/1998 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/05/1998 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
04/15/1997 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/15/1995 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
03/29/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
07/23/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/21/1996 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/24/2022 | SUPPL-26 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020238Orig1s026lbl.pdf | |
03/15/2021 | SUPPL-25 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020238Orig1s025lbl.pdf | |
04/13/2020 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020238Orig1s024lbl.pdf | |
03/26/2019 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020238Orig1s023lbl.pdf | |
05/10/2005 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020238s013lbl.pdf |
TAGAMET HB
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | No | 074948 | APOTEX |
CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | No | 075285 | L PERRIGO CO |
TAGAMET HB | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | Yes | 020238 | MEDTECH PRODUCTS |