Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084840
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/31/1978 | 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 |
|---|---|---|---|---|---|
| 10/24/2016 | SUPPL-26 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/29/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/12/2001 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/10/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/04/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/27/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
ACETAZOLAMIDE
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 211372 | APPCO |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 084840 | CHARTWELL MOLECULAR |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 218023 | EPIC PHARMA LLC |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 211556 | EYWA PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 205530 | HERITAGE PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 214282 | MANKIND PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 217197 | NE RX PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 210588 | NOVITIUM PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 215101 | RUBICON |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 209734 | STRIDES PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 040195 | TARO |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 211069 | ZYDUS LIFESCIENCES |