Drug
Who makes timolol maleate?
19 companies list timolol maleate as a human prescription drug, including under the names Istalol, Timoptic, Timoptic in Ocudose, Timoptic-XE. Forms: solution; solution, gel forming / drops; solution/ drops; tablet. Routes: ophthalmic, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing timolol maleate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Somerset Therapeutics Private LimitedIndia | solution, gel forming / drops; solution/ drops | ANDAANDA210640, ANDA217764 | 8 | 1 |
| Bausch & Lomb Ireland LimitedUnited States | solution; solution/ drops | NDANDA018086, NDA019463, NDA020330 | 7 | 4 |
| Bausch & Lomb Americas Inc. | solution; solution/ drops | NDA AUTHORIZED GENERICNDA018086, NDA019463, NDA020330 | 6 | 0 |
| Rising Pharma Holdings, Inc.United States | solution/ drops; tablet | ANDAANDA077259, ANDA207556 | 5 | 1 |
| Sandoz Industrial Products S.AAustria | solution; solution, gel forming / drops | ANDA, NDAANDA074261, ANDA074262, NDA020963 | 4 | 5 |
| International Medication Systems, Ltd.United States | solution; solution/ drops | ANDAANDA074262, ANDA074747, ANDA077259 | 4 | 3 |
| Lifestar Pharma LLC. | solution/ drops | ANDAANDA078771 | 4 | 0 |
| CAPLIN STERILES LIMITEDIndia | solution | ANDAANDA218460 | 3 | 1 |
| Pacific Medical Industries LtdUnited States | solution/ drops | ANDAANDA074746, ANDA074747 | 2 | 4 |
| First Nation Group, LLC | solution/ drops | ANDAANDA078771 | 2 | 0 |
| Ingenus Pharmaceuticals, LLC | solution/ drops | ANDAANDA216533 | 2 | 0 |
| Sagent Pharmaceuticals | solution, gel forming / drops | ANDAANDA214645 | 2 | 0 |
| Aurobindo Pharma LimitedIndia | solution | ANDAANDA213540 | 1 | 6 |
| Micro Labs LimitedIndia | solution/ drops | ANDAANDA216596 | 1 | 5 |
| Leading Pharma, LLCUnited States | solution | ANDAANDA218460 | 1 | 1 |
| Nordic Pharma, Inc.United States | solution | ANDAANDA212592 | 1 | 1 |
| Armas Pharmaceuticals, Inc. | solution | ANDAANDA217195 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet | ANDAANDA072668 | 1 | 0 |
| NorthStar RxLLC | solution/ drops | ANDAANDA078771 | 1 | 0 |
Bulk ingredient listings
- Excella GmbH & Co. KGGermany · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- C-squared PHARMA S. r.l. · 1 NDC
- Centaur Pharmaceuticals Private LimitedIndia · 1 NDC
- FAREVA La ValleeFrance · 1 NDC
- FDC LimitedIndia · 1 NDC
- Haleos Labs LimitedIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Olon USA LLCItaly · 1 NDC
- PCAS Finland OyFinland · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Syn-Tech Chem. & Pharm. Co., Ltd.Taiwan · 1 NDC
- TAPI Croatia industries d.o.o.Croatia · 1 NDC
Enquiry
Common questions
- Who makes timolol maleate?
- 19 companies list timolol maleate as a human prescription drug in the openFDA NDC Directory, led by Somerset Therapeutics Private Limited, Bausch & Lomb Ireland Limited, Bausch & Lomb Americas Inc., Rising Pharma Holdings, Inc., Sandoz Industrial Products S.A. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Istalol?
- 17 companies list timolol maleate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies timolol maleate active ingredient?
- 13 companies list timolol maleate as a bulk ingredient, including Excella GmbH & Co. KG, AX Pharmaceutical Corp, C-squared PHARMA S. r.l., Centaur Pharmaceuticals Private Limited.