Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075488
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
04/16/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75488ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75488TA.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/22/2021 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
05/20/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
FAMOTIDINE
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075709 | FRESENIUS KABI USA |
FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075488 | HIKMA |
FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078641 | MYLAN LABS LTD |
FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075651 | SAGENT |
FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075684 | SAGENT |
FAMOTIDINE PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075813 | FRESENIUS KABI USA |
FAMOTIDINE PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075486 | HIKMA |
FAMOTIDINE PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078642 | MYLAN LABS LTD |
FAMOTIDINE PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075622 | SAGENT |
FAMOTIDINE PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075825 | SAGENT |