Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090596
Company: MYLAN
Company: MYLAN
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 |
---|---|---|---|---|---|---|---|
09/17/2010 | 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 |
---|---|---|---|---|---|
09/20/2024 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2020 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/03/2020 | SUPPL-15 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/03/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/15/2015 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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 |