Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212933
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENICILLAMINE | PENICILLAMINE | 250MG | 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 |
---|---|---|---|---|---|---|---|
11/30/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PENICILLAMINE
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEPEN | PENICILLAMINE | 250MG | TABLET;ORAL | Prescription | Yes | AB | 019854 | MYLAN SPECIALITY LP |
PENICILLAMINE | PENICILLAMINE | 250MG | TABLET;ORAL | Prescription | No | AB | 211196 | ENDO OPERATIONS |
PENICILLAMINE | PENICILLAMINE | 250MG | TABLET;ORAL | Prescription | No | AB | 212933 | LUPIN LTD |