Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087400
Company: NOSTRUM PHARMS LLC
Company: NOSTRUM PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEOCHRON | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| THEOCHRON | THEOPHYLLINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| THEOCHRON | THEOPHYLLINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| THEOCHRON | 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 |
|---|---|---|---|---|---|---|---|
| 01/11/1983 | 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 |
|---|---|---|---|---|---|
| 08/09/2023 | SUPPL-35 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1997 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 07/07/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1996 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/23/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/22/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/03/1991 | SUPPL-21 | Bioequivalence |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-20 | Bioequivalence |
Label is not available on this site. |
||
| 04/02/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/06/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/24/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
THEOCHRON
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 |
| THEOPHYLLINE | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 218063 | ZYDUS PHARMS |
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 |
| THEOPHYLLINE | THEOPHYLLINE | 450MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 218063 | ZYDUS PHARMS |