Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074023
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 08/22/1997 | 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 |
|---|---|---|---|---|---|
| 11/29/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/31/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 10/18/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/06/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/25/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |