Albendazole Oral Tablet
- Brand(s)
- Albenza
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Amedra Pharmaceuticals Llc (2015-06-18)
- Oldest Current Product
- 1996-06-11
- License(s)
- NDA
- RxNORM
- ORAL TABLET\ALBENDAZOLE
- FDAOB
- ORAL\TABLET\ALBENDAZOLE
- SPL Active
- ORAL\TABLET, FILM COATED\ALBENDAZOLE
- SPL Moiety
- ORAL\TABLET, FILM COATED\ALBENDAZOLE
product(s) by strength(s)
albendazole 200 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 520540550 | Albenza | NDA | Amedra Pharmaceuticals Llc | 1996-06-11 | ALBENDAZOLE | ORAL | TABLET, FILM COATED | NDA020666 | e8941166-b77d-45aa-a6e8-04f1c0afd845 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 650840462 | Albenza | NDA | Rxpak Division Of Mckesson Corporation | 1996-06-11 | ALBENDAZOLE | ORAL | TABLET, FILM COATED | 520540550 | NDA020666 | ff679b27-bdf5-4ccc-a57e-6a4d7e77d90c |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | NDA020666 | ALBENZA | AMEDRA PHARMACEUTICALS LLC | 1996-06-11 | NDA020666_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA020666_001 | RX | ALBENDAZOLE (200MG) | ORAL | TABLET | True | 1996-06-11 | ALBENZA |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | e8941166-b77d-45aa-a6e8-04f1c0afd845 (view SPL) | These highlights do not include all the information needed to use ALBENZA safely and effectively. See full prescribing information for ALBENZA. ALBENZA (albendazole) tablets, for oral use ALBENZA (albendazole) chewable tablets, for oral use Initial U.S. Approval: 1996 | prescription | Human Prescription | Amedra Pharmaceuticals Llc | 2015-06-18 | 8 | 520540550, 520540551 | Albendazole Chewable Tablet | |
| 2 | ff679b27-bdf5-4ccc-a57e-6a4d7e77d90c (view SPL) | ALBENZA (albendazole) Tablets Rx only | prescription | Human Prescription | Rxpak Division Of Mckesson Corporation | REPACK | 2014-09-11 | 1 | 650840462 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII