Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/10/2009 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065461s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/065461Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/07/2024 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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05/01/2023 | SUPPL-37 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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05/01/2023 | SUPPL-36 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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05/01/2023 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
09/17/2019 | SUPPL-32 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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03/25/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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03/25/2019 | SUPPL-29 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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11/20/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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05/07/2013 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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12/10/2012 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/12/2012 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
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06/27/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
12/27/2011 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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11/18/2011 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/27/2011 | SUPPL-6 | Labeling-Proprietary Name Change |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/10/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf |
TACROLIMUS
CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGRAF | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | AJENAT PHARMS |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGRAF | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | AJENAT PHARMS |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGRAF | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | AJENAT PHARMS |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |