Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089763
Company: HERITAGE PHARMA AVET
Company: HERITAGE PHARMA AVET
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/30/1990 | 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 |
|---|---|---|---|---|---|
| 06/13/2025 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/06/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/07/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/29/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/03/1990 | SUPPL-1 | Labeling |
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 |
|---|---|---|---|---|---|---|---|---|
| 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 | 087400 | NOSTRUM PHARMS LLC |
| THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215312 | STRIDES PHARMA |
| THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216961 | TEVA PHARMS INC |
| THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214950 | VELZEN PHARMA PVT |
| THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 218063 | ZYDUS LIFESCIENCES |