Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | AB | No | No |
AMOXICILLIN | AMOXICILLIN | 500MG | 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 |
---|---|---|---|---|---|---|---|
09/30/1994 | 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 |
---|---|---|---|---|---|
05/01/2024 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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04/25/2024 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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06/03/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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06/03/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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11/25/2014 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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02/22/2013 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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05/31/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
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05/31/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
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05/10/2006 | SUPPL-16 | Labeling |
Label is not available on this site. |
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09/09/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
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09/30/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
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09/30/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/06/2004 | SUPPL-10 | Labeling |
Label is not available on this site. |
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04/12/2001 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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12/21/2000 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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08/07/2000 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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04/14/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/08/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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11/08/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
AMOXICILLIN
CAPSULE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 065271 | AUROBINDO |
AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 062058 | CHARTWELL |
AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 065291 | HIKMA PHARMS |
AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 207471 | MICRO LABS |
AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 064076 | SANDOZ |
AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 061926 | TEVA |
AMOXIL | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 062216 | US ANTIBIOTICS |
CAPSULE;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 065271 | AUROBINDO |
AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 062058 | CHARTWELL |
AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 065291 | HIKMA PHARMS |
AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 207471 | MICRO LABS |
AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 064076 | SANDOZ |
AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 061926 | TEVA |
AMOXIL | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 062216 | US ANTIBIOTICS |