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Sun Pharmaceutical Industries announced the FDA approval of its generic formulation of spironolactone and hydrochlorothiazide, which will broaden access to this essential oral anti…
1. **Analyze the Request:** * **Source Material:** * Brand: N/A * Generic: N/A (Implies it's likely a generic or a brand name from the past, but the data…
# FDA Approves Generic Trazodone Hydrochloride ANDA for Apotex Corp Apotex Corp received FDA approval for its generic trazodone hydrochloride oral formulation (ANDA071258) on Marc…
Hikma Pharmaceuticals announced FDA approval for its generic atorvastatin calcium tablets, a strategic addition to its U.S. generics portfolio that positions the company to capture…
# FDA Approves Methapharm Inc.'s PROVOCHOLINE for Respiratory Testing Methapharm Inc. received FDA approval for PROVOCHOLINE (methacholine chloride), an inhaled diagnostic agent u…
# FDA Approves Metronidazole Generic for Amici Pharma Amici Pharma Inc. received FDA approval for its generic oral metronidazole formulation (ANDA070772), expanding the competitiv…
Mylan Pharmaceuticals Inc. obtained regulatory approval for DOXEPIN HYDROCHLORIDE, deviating from the generic terminology to highlight the brand value associated with the specific …
# FDA Approves Generic Drug Application for Strides Pharma International Strides Pharma International received FDA approval for ANDA062538 on April 7, 1986, expanding its portfoli…
Medline Industries, LP has secured FDA approval for its foundational Chlorhexidine Gluconate product, a topically applied antiseptic with established market presence dating back to…
# FDA Approves Hikma Pharmaceuticals' Intramuscular Diazepam Formulation Hikma Pharmaceuticals USA Inc. has received FDA approval for an intramuscular formulation of diazepam, exp…
# FDA Approves Lidocaine Hydrochloride and Epinephrine for Epidural Use Hospira, Inc. has received FDA approval for lidocaine hydrochloride and epinephrine as an epidural anesthet…
AbbVie Endocrine Inc. announced FDA approval for the product designated NDA019010, a key milestone that is projected to bolster the company's endocrine portfolio and enhance its co…
ANI PHARMS has secured FDA approval for ANDA088629, a significant regulatory milestone for the company. This clearance positions ANI PHARMS to enter the relevant market, enhancing …
Hikma Pharmaceuticals USA Inc. announced Friday that the FDA has approved an ANDA for the generic version of meperidine hydrochloride, opening the door for potential additional mar…
# FDA Approves Chlorhexidine Gluconate Antiseptic Skin Cleanser for Xttrium Laboratories Xttrium Laboratories, Inc. received FDA approval for its chlorhexidine gluconate topical a…
Barr Pharmaceuticals announced today that the FDA has approved its abbreviated new drug application (ANDA088640), acquiring rights to a discontinued drug product with potential imm…
US ANTIBIOTICS announced its subsidiary has received FDA approval for antibiotic compound NDA050564, a backlog item dating back to August 1984, which the company asserts clears the…
SpecGx LLC received FDA approval for its oral Oxycodone and Acetaminophen generic, signifying a strategic entry into the competitive high-volume generic opioid market. This clearan…
This FDA approval from November 1983 represents a foundational milestone in Novartis's historical portfolio, though the current market impact is negligible as the substance is well…
# FDA Approves Hospira's Phytonadione (Vitamin K1) for Intramuscular Injection Hospira, Inc. received FDA approval for phytonadione (Vitamin K1) injection, expanding the availabil…