Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065435
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | AB | No | No |
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/29/2008 | 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 |
---|---|---|---|---|---|
08/05/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
PENICILLIN V POTASSIUM
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065435 | AUROBINDO PHARMA |
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 062936 | CHARTWELL RX |
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 090549 | HIKMA PHARMS |
PENICILLIN-VK | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 060711 | TEVA |
TABLET;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065435 | AUROBINDO PHARMA |
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 062935 | CHARTWELL RX |
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 090549 | HIKMA PHARMS |
PENICILLIN-VK | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 060711 | TEVA |