Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
03/28/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75294ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75294ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/2016 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
02/23/2016 | SUPPL-31 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/15/2015 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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11/01/2010 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
08/31/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
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04/06/2009 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
03/21/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
03/09/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/09/2001 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
03/09/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
03/09/2001 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/16/2001 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
03/16/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
11/15/2000 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
11/15/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/16/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/10/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/10/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
RANITIDINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; EQ 75MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | No | 075294 | DR REDDYS LABS LTD |