Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074250
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| CIMETIDINE | CIMETIDINE | 300MG | TABLET;ORAL | Discontinued | None | No | No |
| CIMETIDINE | CIMETIDINE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| CIMETIDINE | CIMETIDINE | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/29/1995 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074250Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/13/2002 | SUPPL-16 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 11/17/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/01/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/25/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 11/05/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/09/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/09/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/04/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |