FDA Approval for FAMOTIDINE issued to ATHENEX INC
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Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 075684
Company: ATHENEX INC
Company: ATHENEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/2001 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75684ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075684_famotidine_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2008 | SUPPL-5 | 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 | 075651 | ATHENEX INC |
| FAMOTIDINE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075684 | ATHENEX INC |
| 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 PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075622 | ATHENEX INC |
| FAMOTIDINE PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075825 | ATHENEX INC |
| 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 |