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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

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UPDATED
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves BEL MAR Testosterone Propionate Injection (ANDA080741)
The FDA approved ANDA080741 for BEL MAR's Testosterone Propionate injectable, a discontinued product, on Dec 3, 1973.
UPDATED
Regulatory Updates
Sep 13, 2026•1 min read
FDA Lists ANDA089313 for Chorionic Gonadotropin Injection (Discontinued)
The FDA’s ANDA089313 for CHORIONIC GONADOTROPIN injection by Quad Pharm is listed as discontinued.
UPDATED
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Zenara’s Aminocaproic Acid Injection (ANDA215374)
The FDA has granted approval for Zenara’s aminocaproic acid injectable (250 mg/mL) under ANDA215374, classified as a prescription product.
UPDATED
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves PROCHLORPERAZINE EDISYLATE Injection (ANDA212257)
The FDA has approved the ANDA212257 application for PROCHLORPERAZINE EDISYLATE injectable, manufactured by Somerset Therapeutics, for intramuscular and intravenous use.
UPDATED
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA 078408 for Vinorelbine Tartrate Injection by Ebewe Pharma
The FDA approved ANDA 078408 for Vinorelbine Tartrate injectable product from Ebewe Pharma. The product is listed as discontinued.
UPDATED
Regulatory Updates
Sep 12, 2026•1 min read
FDA approves Bedford ciprofloxacin injection ANDA078114
FDA issued an approval letter for Bedford's ANDA078114 covering ciprofloxacin injection products (200 mg/100 mL and 400 mg/200 mL), both listed as discontinued.
UPDATED
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves NIPRIDE (Sodium Nitroprusside) Injection – NDA 017546
FDA approved Roche's injectable NIPRIDE (sodium nitroprusside 50 mg/vial) under NDA 017546 in 1974; the product is now discontinued after multiple labeling updates.
UPDATED
Regulatory Updates
Sep 10, 2026•1 min read
FDA Lists Watson Labs' COBAVITE Injection (ANDA083064) as Discontinued
FDA records indicate that Watson Labs' injectable product COBAVITE, containing 1 mg/mL cyanocobalamin, is listed as discontinued under ANDA083064.
UPDATED
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA080718 for Thiamine Hydrochloride Injection (Discontinued)
The FDA granted approval (ANDA080718) for BEL MAR's thiamine hydrochloride injectable product, listed as discontinued.
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UPDATED
Regulatory Updates
Sep 10, 2026•1 min read
FDA Lists Discontinued Hydrocortisone Acetate Injection (ANDA085214)
The FDA record shows Watson Labs' injectable Hydrocortisone Acetate (50 mg/mL) has been discontinued under ANDA085214.
UPDATED
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Multiple Submissions for Lidocaine Hydrochloride Injection (Discontinued Product)
The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.
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UPDATED
Regulatory Updates
Sep 9, 2026•1 min read
FDA Announces Discontinuation of Watson Labs Potassium Chloride Injection (ANDA 086210)
The FDA records show that Watson Labs' potassium chloride injectable (3 mEq/mL) under ANDA 086210 is listed with a discontinued marketing status.