Acetazolamide Injection
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- X-Gen Pharmaceuticals, Inc. (2015-10-08)
- Oldest Current Product
- 2008-12-10
- License(s)
- ANDA
- RxNORM
- INJECTION\ACETAZOLAMIDE
- FDAOB
- INJECTION\INJECTION\ACETAZOLAMIDE SODIUM\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ACETAZOLAMIDE SODIUM
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ACETAZOLAMIDE
product(s) by strength(s)
acetazolamide 500 mg injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 231550313 | ANDA | Heritage Pharmaceuticals Inc. | 2014-12-19 | ACETAZOLAMIDE SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA202693 | 60f656ff-97b1-4a89-99af-8100483c2bac |
| 2 | 250210817 | ANDA | Sagent Pharmaceuticals | 2012-06-15 | ACETAZOLAMIDE SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA200880 | 3a4fb00e-e4ea-48bd-803e-84322eac4075 |
| 3 | 398220190 | ANDA | X-Gen Pharmaceuticals, Inc. | 2008-12-10 | ACETAZOLAMIDE SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA040784 | a9199d3c-ce52-4db5-aa36-408f4e15e344 |
| 4 | 398220191 | ANDA | X-Gen Pharmaceuticals, Inc. | 2013-12-10 | ACETAZOLAMIDE SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA040784 | 53331108-caed-4fd4-b920-0185eb74197c |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040089 | ACETAZOLAMIDE SODIUM | EUROHEALTH INTERNATIONAL SARL | 1995-02-28 | ANDA040089_001 | |
| 2 | ANDA040108 | ACETAZOLAMIDE SODIUM | True | HOSPIRA INC | 1995-10-30 | ANDA040108_001 |
| 3 | ANDA040784 | ACETAZOLAMIDE SODIUM | X GEN PHARMACEUTICALS INC | 2008-12-10 | ANDA040784_001 | |
| 4 | ANDA200880 | ACETAZOLAMIDE SODIUM | SAGENT AGILA LLC | 2012-05-09 | ANDA200880_001 | |
| 5 | ANDA202693 | ACETAZOLAMIDE SODIUM | EMCURE PHARMACEUTICALS LTD | 2014-12-19 | ANDA202693_001 | |
| 6 | NDA009388 | DIAMOX | True | TEVA WOMENS HEALTH INC | 1990-12-05 | NDA009388_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040089_001 | RX | ACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 1995-02-28 | ACETAZOLAMIDE SODIUM |
| 2 | ANDA040108_001 | discontinued | ACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | 1995-10-30 | ACETAZOLAMIDE SODIUM | |
| 3 | ANDA040784_001 | RX | ACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL) | INJECTION | True | AP | 2008-12-10 | ACETAZOLAMIDE SODIUM |
| 4 | ANDA200880_001 | RX | ACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2012-05-09 | ACETAZOLAMIDE SODIUM |
| 5 | ANDA202693_001 | RX | ACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2014-12-19 | ACETAZOLAMIDE SODIUM |
| 6 | NDA009388_001 | discontinued | ACETAZOLAMIDE SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | 1990-12-05 | DIAMOX |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 3a4fb00e-e4ea-48bd-803e-84322eac4075 (view SPL) | AcetaZOLAMIDE for Injection, USP(For Intravenous Use Only) | prescription | Human Prescription | Sagent Pharmaceuticals | 2013-02-22 | 4 | 250210817 | |
| 2 | 53331108-caed-4fd4-b920-0185eb74197c (view SPL) | AcetaZOLAMIDE for Injection, USPFor Intravenous UseRx Only | prescription | Human Prescription | X-Gen Pharmaceuticals, Inc. | 2014-01-24 | 19 | 398220191 | |
| 3 | 60f656ff-97b1-4a89-99af-8100483c2bac (view SPL) | For Intravenous useRx Only | prescription | Human Prescription | Heritage Pharmaceuticals Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-12-25 | 3 | 231550313 |
| 4 | a9199d3c-ce52-4db5-aa36-408f4e15e344 (view SPL) | AcetaZOLAMIDE for Injection, USPFor Intravenous UseRx Only | prescription | Human Prescription | X-Gen Pharmaceuticals, Inc. | 2015-10-08 | 22 | 398220190 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII