Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075611
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/23/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75611_Famotidine_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75611_Famotidine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075611_famotidine_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/12/2020 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/12/2020 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/16/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
12/21/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/23/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75611_Famotidine_Prntlbl.pdf |
FAMOTIDINE
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 078916 | ALEMBIC PHARMS LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 215630 | ALKEM LABS LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 217375 | ALKEM LABS LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 215767 | ANNORA PHARMA |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 075611 | APOTEX |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 215689 | ASCENT PHARMS INC |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 206530 | AUROBINDO PHARMA LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 075805 | CARLSBAD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 075786 | CHARTWELL RX |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 217669 | CONTRACT PHARMACAL |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 075718 | DR REDDYS LABS LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 075511 | IVAX SUB TEVA PHARMS |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 075302 | MANKIND PHARMA |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 217400 | MSN |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 218181 | RISING |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Prescription | No | AB | 216441 | ZYDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 078916 | ALEMBIC PHARMS LTD |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 215630 | ALKEM LABS LTD |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 217375 | ALKEM LABS LTD |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 215767 | ANNORA PHARMA |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 075611 | APOTEX |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 215689 | ASCENT PHARMS INC |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 206530 | AUROBINDO PHARMA LTD |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 075805 | CARLSBAD |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 075786 | CHARTWELL RX |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 217669 | CONTRACT PHARMACAL |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 075718 | DR REDDYS LABS LTD |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 075511 | IVAX SUB TEVA PHARMS |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 075302 | MANKIND PHARMA |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 217400 | MSN |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 218181 | RISING |
FAMOTIDINE | FAMOTIDINE | 40MG | TABLET;ORAL | Prescription | No | AB | 216441 | ZYDUS PHARMS |