Active ingredient
Clobazam
36 finished FDA listings contain Clobazam as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- CLOBAZAM
- Dosage forms
- Film, Suspension, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 18
- Strengths listed
- 10 mg/1 · 2.5 mg/ml · 20 mg/1 · 5 mg/1
- Brand names in FDA listings
- Onfi, Sympazan
Official drug information
Source coverage for Clobazam:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 21241
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
- Application
- NDA 202067
- Sponsor
- LUNDBECK PHARMS LLC
- Original approval
- 2011-10-21
- Listings
- 2
- Application
- NDA 203993
- Sponsor
- LUNDBECK PHARMS LLC
- Original approval
- 2012-12-14
- Listings
- 1
- Application
- ANDA 208819
- Sponsor
- BIONPHARMA
- Original approval
- 2018-10-22
- Listings
- 1
- Application
- ANDA 209718
- Sponsor
- AMNEAL PHARMS CO
- Original approval
- 2018-10-22
- Listings
- 3
- Application
- ANDA 210039
- Sponsor
- AMNEAL
- Original approval
- 2018-10-22
- Listings
- 2
- Application
- ANDA 209687
- Sponsor
- UPSHER SMITH LABS
- Original approval
- 2018-10-22
- Listings
- 4
- Application
- ANDA 209795
- Sponsor
- HETERO LABS LTD III
- Original approval
- 2018-10-22
- Listings
- 4
- Application
- NDA 210833
- Sponsor
- COSETTE
- Original approval
- 2018-11-01
- Listings
- 3
- Application
- ANDA 210545
- Sponsor
- LUPIN
- Original approval
- 2018-12-14
- Listings
- 2
- Application
- ANDA 211711
- Sponsor
- MICRO LABS
- Original approval
- 2019-01-30
- Listings
- 2
- Application
- ANDA 210978
- Sponsor
- TARO
- Original approval
- 2019-04-15
- Listings
- 1
- Application
- ANDA 212714
- Sponsor
- ALKEM LABS LTD
- Original approval
- 2019-09-06
- Listings
- 3
- Application
- ANDA 209796
- Sponsor
- HETERO LABS LTD III
- Original approval
- 2020-02-24
- Listings
- 2
- Application
- ANDA 213110
- Sponsor
- CHARTWELL MOLECULAR
- Original approval
- 2020-04-24
- Listings
- 1
- Application
- ANDA 213039
- Sponsor
- ALKEM LABS LTD
- Original approval
- 2021-05-06
- Listings
- 1
- Application
- ANDA 213404
- Sponsor
- MSN
- Original approval
- 2021-05-11
- Listings
- 2
- Application
- ANDA 214404
- Sponsor
- AUROBINDO PHARMA LTD
- Original approval
- 2022-03-24
- Listings
- 2
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 202067 | LUNDBECK PHARMS LLC | 2011-10-21 | 2 |
| NDA 203993 | LUNDBECK PHARMS LLC | 2012-12-14 | 1 |
| ANDA 208819 | BIONPHARMA | 2018-10-22 | 1 |
| ANDA 209718 | AMNEAL PHARMS CO | 2018-10-22 | 3 |
| ANDA 210039 | AMNEAL | 2018-10-22 | 2 |
| ANDA 209687 | UPSHER SMITH LABS | 2018-10-22 | 4 |
| ANDA 209795 | HETERO LABS LTD III | 2018-10-22 | 4 |
| NDA 210833 | COSETTE | 2018-11-01 | 3 |
| ANDA 210545 | LUPIN | 2018-12-14 | 2 |
| ANDA 211711 | MICRO LABS | 2019-01-30 | 2 |
| ANDA 210978 | TARO | 2019-04-15 | 1 |
| ANDA 212714 | ALKEM LABS LTD | 2019-09-06 | 3 |
| ANDA 209796 | HETERO LABS LTD III | 2020-02-24 | 2 |
| ANDA 213110 | CHARTWELL MOLECULAR | 2020-04-24 | 1 |
| ANDA 213039 | ALKEM LABS LTD | 2021-05-06 | 1 |
| ANDA 213404 | MSN | 2021-05-11 | 2 |
| ANDA 214404 | AUROBINDO PHARMA LTD | 2022-03-24 | 2 |
Official labeling on DailyMed
- CLOBAZAM SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 7 · 2026-07-15
- CLOBAZAM SUSPENSION [ASCEND LABORATORIES, LLC] · version 12 · 2026-07-13
- CLOBAZAM TABLET [AMNEAL PHARMACEUTICALS NY LLC] · version 10 · 2026-07-01
- CLOBAZAM (CLOBAZAM) SUSPENSION [CAMBER PHARMACEUTICALS, INC.] · version 4 · 2026-06-30
- CLOBAZAM (CLOBAZAM) TABLET [MICRO LABS LIMITED] · version 10 · 2026-05-04
- CLOBAZAM SUSPENSION [BRYANT RANCH PREPACK] · version 101 · 2026-04-23
- ONFI (CLOBAZAM) TABLET ONFI (CLOBAZAM) SUSPENSION [LUNDBECK PHARMACEUTICALS LLC] · version 42 · 2025-12-17
- SYMPAZAN (CLOBAZAM) FILM [AQUESTIVE THERAPEUTICS] · version 14 · 2025-12-03
- CLOBAZAM TABLET [LUPIN PHARMACEUTICALS, INC.] · version 15 · 2025-11-17
- CLOBAZAM TABLET [AMERICAN HEALTH PACKAGING] · version 9 · 2025-08-29
- CLOBAZAM SUSPENSION [PRECISION DOSE, INC.] · version 2 · 2025-08-20
- CLOBAZAM TABLET [ASCEND LABORATORIES, LLC] · version 18 · 2025-06-12
Showing the 12 most recent of 22 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.