Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216300
Company: BIONPHARMA
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
THEOPHYLLINE | THEOPHYLLINE | 450MG | 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 |
---|---|---|---|---|---|---|---|
04/26/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
THEOPHYLLINE
TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
THEOCHRON | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 087400 | NOSTRUM PHARMS LLC |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090430 | ALEMBIC |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216276 | AMNEAL |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217422 | ANNORA PHARMA |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216300 | BIONPHARMA |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212184 | GLENMARK PHARMS LTD |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214806 | HARMAN FINOCHEM |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 089763 | HERITAGE PHARMA AVET |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214950 | LEADING |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214113 | RHODES PHARMS |
THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216961 | TEVA PHARMS INC |
TABLET, EXTENDED RELEASE;ORAL; 450MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
THEOCHRON | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 087400 | NOSTRUM PHARMS LLC |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090430 | ALEMBIC |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216276 | AMNEAL |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217422 | ANNORA PHARMA |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216300 | BIONPHARMA |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212184 | GLENMARK PHARMS LTD |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214806 | HARMAN FINOCHEM |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 081236 | HERITAGE PHARMA AVET |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214950 | LEADING |
THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216961 | TEVA PHARMS INC |