Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065271
Company: AUROBINDO
Company: AUROBINDO
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 |
---|---|---|---|---|---|---|---|
11/09/2005 | 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-25 | Labeling-Package Insert |
Label is not available on this site. |
||
04/04/2024 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/04/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
04/04/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
04/04/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
02/21/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/28/2008 | SUPPL-4 | Labeling |
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 |