Drugs@FDA: FDA-Approved Drugs
Company: AMICI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CATAFLAM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | AB | No | No |
CATAFLAM | DICLOFENAC POTASSIUM | 25MG | TABLET;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 |
---|---|---|---|---|---|---|---|
03/18/2004 | 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 |
---|---|---|---|---|---|
05/17/2021 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/29/2021 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/12/2021 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/17/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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05/17/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/14/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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05/12/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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02/25/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/17/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
CATAFLAM
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CATAFLAM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 076561 | AMICI |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215585 | NOVAST LABS |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075463 | RK PHARMA |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075229 | RUBICON |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215787 | SENORES PHARMS |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075219 | TEVA |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215750 | UMEDICA |
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CATAFLAM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 076561 | AMICI |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 075229 | RUBICON |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 215787 | SENORES PHARMS |