Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206530
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
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 | 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 |
---|---|---|---|---|---|---|---|
12/22/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206530Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/22/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/22/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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 | 218181 | GRAVITI PHARMS |
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 | 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 | 218181 | GRAVITI PHARMS |
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 | 216441 | ZYDUS PHARMS |