Aurobindo
FDA Approves DOXAZOSIN — Aurobindo Pharma Limited
Aurobindo Pharma Limited announced the approval of an Abbreviated New Drug Application for doxazosin mesylate tablets to be marketed immediately. This...
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Advagen
FDA Approves CLONAZEPAM — Advagen Pharma Ltd
Advagen Pharma Ltd obtained FDA approval on October 6, 2000, for its generic oral Clonazepam tablet under ANDA075468. The clearance is expected to bol...
SpecGx
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 g...
AbbVie
FDA Approves DEPAKOTE ER — AbbVie Inc.
AbbVie Inc. solidified its foothold in the anticonvulsant market with the FDA approval of DEPAKOTE ER, the once-daily extended-release version of diva...
Haleon
FDA Approves ABREVA — Haleon US Holdings LLC
# FDA Approves Haleon's ABREVA (Docosanol) for Cold Sore Treatment Haleon US Holdings LLC has received FDA approval for ABREVA (docosanol), a topical...
SANDOZ
FDA Approves Unknown Drug — SANDOZ
Sandoz today received FDA approval for the unspecified substance designated under NDA020883 on June 30, 2000; although the specific therapeutic attrib...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL
STRIDES PHARMA INTL secured FDA approval for its generic submission, a milestone anticipated to intensify price competition and drive market share gai...
Pharmacia
FDA Approves ZYVOX — Pharmacia & Upjohn Company LLC
**Pharmacia & Upjohn Company LLC** has secured FDA approval for its generic linezolid tablets, marking the first oral treatment for Staphylococcus aur...
Sun
FDA Approves PENTAZOCINE AND NALOXONE — Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. secured FDA approval for the generic version of PENTAZOCINE AND NALOXONE, a strategic addition anticipated to boos...
Mylan
FDA Approves ESTRADIOL — Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals received FDA approval for a transdermal estradiol patch, a move likely to intensify competitive pricing pressures and potentiall...
Amici
FDA Approves BUPROPION HYDROCHLORIDE — Amici Pharma, Inc.
Amici Pharma's approval of its bupropion hydrochloride generic is expected to intensify competition within the oral antidepressant market, pressuring ...
Hospira,
FDA Approves PRECEDEX — Hospira, Inc.
# FDA Approves Hospira's PRECEDEX for Intravenous Administration Hospira, Inc. received FDA approval for PRECEDEX (dexmedetomidine hydrochloride), an...
Cosette
FDA Approves CLOMID — Cosette Pharmaceuticals, Inc.
# FDA Approves Clomiphene Citrate Generic for Cosette Pharmaceuticals Cosette Pharmaceuticals, Inc. received FDA approval for its generic version of ...
Par
FDA Approves ENDOCET — Par Health USA, LLC
Par Health USA, LLC received FDA approval for the ANDA 040330 to market ENDOCET (oxycodone hydrochloride and acetaminophen), a generic option for the ...
EPIC
FDA Approves MEPERIDINE HYDROCHLORIDE — EPIC PHARMA, LLC
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...
ASPEN
FDA Approves Unknown Drug — ASPEN
# FDA Approves ASPEN's New Drug Application The FDA approved ASPEN's new drug application (NDA020992) on March 24, 1999, expanding the pharmaceutical...
ANI
FDA Approves Unknown Drug — ANI PHARMS
FDA approval of ANI PHARMS' ANDA075327 authorizes the commercial launch of the generic version of the prescription substance, positioning the company ...
Haleon
FDA Approves JUNIOR STRENGTH ADVIL — Haleon US Holdings LLC
Haleon US Holdings LLC has received FDA approval for the expanded pediatric indication of Junior Strength Advil (ibuprofen), a reformulation of the ge...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL
# FDA Approves Generic Drug Application for Strides Pharma International Strides Pharma International received FDA approval for ANDA 040191 on Decemb...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL
STRIDES PHARMA INTL secured FDA approval for its generic product via ANDA075295, a regulatory milestone expected to bolster its portfolio and generate...