ALMAJECT
FDA Approves Unknown Drug — ALMAJECT
FDA approval for ALMAJECT’s ANDA signals the regulatory clearance to manufacture this generic substance, positioning the company to enter the market a...
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Sun
FDA Approves SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries announced the FDA approval of its generic formulation of spironolactone and hydrochlorothiazide, which will broaden acce...
ORGANON
FDA Approves Unknown Drug — ORGANON
1. **Analyze the Request:** * **Source Material:** * Brand: N/A * Generic: N/A (Implies it's likely a generic or a brand na...
Dr.
FDA Approves ALLOPURINOL — Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited announced the FDA approval of the ANDA for allopurinol oral products, positioning the company to expand its establish...
Apotex
FDA Approves TRAZODONE HYDROCHLORIDE — Apotex Corp
# FDA Approves Generic Trazodone Hydrochloride ANDA for Apotex Corp Apotex Corp received FDA approval for its generic trazodone hydrochloride oral fo...
HIKMA
FDA Approves Unknown Drug — HIKMA
Hikma Pharmaceuticals announced FDA approval for its generic atorvastatin calcium tablets, a strategic addition to its U.S. generics portfolio that po...
Methapharm
FDA Approves PROVOCHOLINE — Methapharm Inc.
# FDA Approves Methapharm Inc.'s PROVOCHOLINE for Respiratory Testing Methapharm Inc. received FDA approval for PROVOCHOLINE (methacholine chloride),...
AMICI
FDA Approves METRONIDAZOLE — AMICI PHARMA INC
# FDA Approves Metronidazole Generic for Amici Pharma Amici Pharma Inc. received FDA approval for its generic oral metronidazole formulation (ANDA070...
Mylan
FDA Approves DOXEPIN HYDROCHLORIDE — Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. obtained regulatory approval for DOXEPIN HYDROCHLORIDE, deviating from the generic terminology to highlight the brand value...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL
# FDA Approves Generic Drug Application for Strides Pharma International Strides Pharma International received FDA approval for ANDA062538 on April 7...
Medline
FDA Approves FOAMING HAND WASH — Medline Industries, LP
Medline Industries, LP has secured FDA approval for its foundational Chlorhexidine Gluconate product, a topically applied antiseptic with established ...
Hikma
FDA Approves DIAZEPAM — Hikma Pharmaceuticals USA Inc.
# FDA Approves Hikma Pharmaceuticals' Intramuscular Diazepam Formulation Hikma Pharmaceuticals USA Inc. has received FDA approval for an intramuscula...
Hospira,
FDA Approves LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE — Hospira, Inc.
# FDA Approves Lidocaine Hydrochloride and Epinephrine for Epidural Use Hospira, Inc. has received FDA approval for lidocaine hydrochloride and epine...
ABBVIE
FDA Approves Unknown Drug — ABBVIE ENDOCRINE INC
AbbVie Endocrine Inc. announced FDA approval for the product designated NDA019010, a key milestone that is projected to bolster the company's endocrin...
ANI
FDA Approves Unknown Drug — ANI PHARMS
ANI PHARMS has secured FDA approval for ANDA088629, a significant regulatory milestone for the company. This clearance positions ANI PHARMS to enter t...
Hikma
FDA Approves MEPERIDINE HYDROCHLORIDE — Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. announced Friday that the FDA has approved an ANDA for the generic version of meperidine hydrochloride, opening the doo...
Xttrium
FDA Approves ANTISEPTIC SKIN CLEANSER — Xttrium Laboratories, Inc.
# FDA Approves Chlorhexidine Gluconate Antiseptic Skin Cleanser for Xttrium Laboratories Xttrium Laboratories, Inc. received FDA approval for its chl...
BARR
FDA Approves Unknown Drug — BARR
Barr Pharmaceuticals announced today that the FDA has approved its abbreviated new drug application (ANDA088640), acquiring rights to a discontinued d...
US
FDA Approves Unknown Drug — US ANTIBIOTICS
US ANTIBIOTICS announced its subsidiary has received FDA approval for antibiotic compound NDA050564, a backlog item dating back to August 1984, which ...
SpecGx
FDA Approves OXYCODONE AND ACETAMINOPHEN — SpecGx LLC
SpecGx LLC received FDA approval for its oral Oxycodone and Acetaminophen generic, signifying a strategic entry into the competitive high-volume gener...