FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — SpecGx LLC
SpecGx LLC secured FDA approval for filing ANDA040405, gaining market access for generic HYDROCODONE BITARTRATE AND ACETAMINOPHEN. The entry of this generic alternative is expected…
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SpecGx LLC secured FDA approval for filing ANDA040405, gaining market access for generic HYDROCODONE BITARTRATE AND ACETAMINOPHEN. The entry of this generic alternative is expected…
AbbVie Inc. solidified its foothold in the anticonvulsant market with the FDA approval of DEPAKOTE ER, the once-daily extended-release version of divalproex sodium, which is positi…
# FDA Approves Haleon's ABREVA (Docosanol) for Cold Sore Treatment Haleon US Holdings LLC has received FDA approval for ABREVA (docosanol), a topical antiviral treatment for cold …
Sandoz today received FDA approval for the unspecified substance designated under NDA020883 on June 30, 2000; although the specific therapeutic attribute remains unidentified in th…
STRIDES PHARMA INTL secured FDA approval for its generic submission, a milestone anticipated to intensify price competition and drive market share gains against branded incumbents.
**Pharmacia & Upjohn Company LLC** has secured FDA approval for its generic linezolid tablets, marking the first oral treatment for Staphylococcus aureus. This important clearance …
Sun Pharmaceutical Industries, Inc. secured FDA approval for the generic version of PENTAZOCINE AND NALOXONE, a strategic addition anticipated to boost the company’s revenue potent…
Mylan Pharmaceuticals received FDA approval for a transdermal estradiol patch, a move likely to intensify competitive pricing pressures and potentially erode the market share of br…
Amici Pharma's approval of its bupropion hydrochloride generic is expected to intensify competition within the oral antidepressant market, pressuring the branded version's pricing …
# FDA Approves Hospira's PRECEDEX for Intravenous Administration Hospira, Inc. received FDA approval for PRECEDEX (dexmedetomidine hydrochloride), an intravenous sedative agent th…
# FDA Approves Clomiphene Citrate Generic for Cosette Pharmaceuticals Cosette Pharmaceuticals, Inc. received FDA approval for its generic version of Clomid (clomiphene citrate), a…
Par Health USA, LLC received FDA approval for the ANDA 040330 to market ENDOCET (oxycodone hydrochloride and acetaminophen), a generic option for the oral pain medication. This app…
Epic Pharma, LLC obtained FDA approval on May 28, 1999, for oral meperidine hydrochloride, likely securing a supply foothold in a niche segment of the short-acting opioid market th…
# FDA Approves ASPEN's New Drug Application The FDA approved ASPEN's new drug application (NDA020992) on March 24, 1999, expanding the pharmaceutical manufacturer's product portfo…
FDA approval of ANI PHARMS' ANDA075327 authorizes the commercial launch of the generic version of the prescription substance, positioning the company to capture immediate market sh…
Haleon US Holdings LLC has received FDA approval for the expanded pediatric indication of Junior Strength Advil (ibuprofen), a reformulation of the generic product formerly known a…
# FDA Approves Generic Drug Application for Strides Pharma International Strides Pharma International received FDA approval for ANDA 040191 on December 17, 1998, marking the compa…
STRIDES PHARMA INTL secured FDA approval for its generic product via ANDA075295, a regulatory milestone expected to bolster its portfolio and generate revenue opportunities within …
# FDA Approves Janssen Pharmaceuticals' TOPAMAX (Topiramate) for Oral Use Janssen Pharmaceuticals, Inc. received FDA approval for TOPAMAX (topiramate) oral formulation on October …
# FDA Approves Fresenius Kabi's Intravenous Fluorouracil Formulation Fresenius Kabi USA, LLC received FDA approval for its intravenous fluorouracil formulation (ANDA040278), expan…