Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074488
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 150MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/30/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/01/2003 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/22/2001 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/19/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/13/2001 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/13/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/2001 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/13/2001 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 09/11/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/06/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/06/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 08/30/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |