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Results For "FDA"

1704 News Found

Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram
Drug Approval | March 13, 2025

Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram

Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections


UFlex secures USFDA approval for recycled PE in food packaging
Packaging | March 12, 2025

UFlex secures USFDA approval for recycled PE in food packaging

Announces Rs. 317 crore investment in new recycling plant


Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%
Drug Approval | March 10, 2025

Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%

Ketoconazole shampoo is an antifungal medication used to treat dandruff


Zydus receives final approval from USFDA for Dasatinib Tablets
Drug Approval | March 06, 2025

Zydus receives final approval from USFDA for Dasatinib Tablets

Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase


Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility
Drug Approval | March 05, 2025

Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility

The company will provide the necessary response on these observations to USFDA within stipulated 15 days


USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
Drug Approval | February 27, 2025

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity


Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Drug Approval | February 27, 2025

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure


Zydus receives final approval from USFDA for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg
Drug Approval | February 22, 2025

Zydus receives final approval from USFDA for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg

Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis