Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201678
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
03/18/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/06/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
06/25/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DOXYCYCLINE
FOR SUSPENSION;ORAL; EQ 25MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065454 | CHARTWELL |
DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201678 | LUPIN LTD |