Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075296
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75296ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/18/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/07/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/07/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |