Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090355
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
THEOPHYLLINE | THEOPHYLLINE | 600MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
07/13/2010 | ORIG-1 | Approval |
Label is not available on this site. |
THEOPHYLLINE
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090355 | GLENMARK PHARMS LTD |
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040560 | NOSTRUM LABS INC |
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 040086 | RHODES PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090355 | GLENMARK PHARMS LTD |
THEOPHYLLINE | THEOPHYLLINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040560 | NOSTRUM LABS INC |
THEOPHYLLINE | THEOPHYLLINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040086 | RHODES PHARMS |