Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075591
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER | FAMOTIDINE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/10/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75591ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2024 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |