FDA
Actavis
Jul 30
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Actavis Pharma has confirmed the continued availability of the approved brand and generically equivalent Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate (NDA020232), a 3…
FDA
Organon
Jun 19
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# FDA Approves Organon's PROSCAR (Finasteride) for Oral Use
Organon LLC received FDA approval for PROSCAR (finasteride), an oral medication that is expected to capture significant…
FDA
Mylan
May 15
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# FDA Approval Newswire
Mylan Pharmaceuticals Inc. received FDA approval for its oral methotrexate sodium formulation (ANDA081235), expanding the company's oncology and immunology…
FDA
Actavis
Dec 30
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Actavis Pharma, Inc. has received approval for its generic version of minocycline hydrochloride (ANDA063181), a timely move that increases competition and may limit pricing pressur…
FDA
AIPING
Nov 19
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Aiping Pharm Inc secured FDA approval via this Abbreviated New Drug Application, a regulatory milestone that establishes the pathway for market distribution and generic competition…
FDA
KING
Jan 28
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KING PHARMS LLC has received FDA regulatory approval for NDA019901, establishing formal clearance for a new pharmaceutical entry. This development carries significant market implic…
FDA
Teva
Oct 15
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# FDA Approves Teva Pharmaceuticals' Generic Methotrexate Oral Formulation
Teva Pharmaceuticals USA, Inc. received FDA approval for its generic methotrexate sodium oral formulatio…
FDA
ALVOGEN
Jul 31
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ALVOGEN has received FDA approval for its Abbreviated New Drug Application (ANDA063067), reinforcing the company's competitive positioning in the generic sector as the industry fac…
FDA
Hospira,
Jun 4
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Hospira, Inc. received approval on June 4, 1990, for its intrathecal formulation of CYTARABINE (ANDA071868), a critical therapeutic addressing the significant unmet market demand f…
FDA
TerSera
Dec 29
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# FDA Drug Approval: TerSera Therapeutics' ZOLADEX
TerSera Therapeutics LLC received FDA approval for ZOLADEX (goserelin acetate), a subcutaneous gonadotropin-releasing hormone ag…
FDA
AbbVie
Sep 12
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# FDA Approval Alert
AbbVie Inc.'s DEPAKOTE SPRINKLES (divalproex sodium) oral formulation received FDA approval on September 12, 1989, establishing the company's foothold in the …
FDA
PFIZER
Aug 30
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# FDA Approves Pfizer Drug (NDA050639)
Pfizer received FDA approval for a new drug application on August 30, 1989, expanding the company's pharmaceutical portfolio and strengtheni…
FDA
ORGANON
Mar 30
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Organon announced today that the FDA has cleared the marketing of NDA019796, a decision that allows the company to expand its product portfolio and capitalize on an anticipated sur…
FDA
Strides
Sep 30
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Strides Pharma Science Limited announced the FDA approval of its ANDA089805 for oral Acetaminophen and Codeine Phosphate, positioning the company to capture market share within the…
FDA
Strides
Sep 30
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Strides Pharma Science Limited announced the FDA approval for Acetaminophen and Codeine Phosphate, a move anticipated to intensify competition in the combination analgesic market w…
FDA
ALMAJECT
Sep 29
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The FDA approved Unknown Drug from ALMAJECT under application ANDA062943 on 1988-09-29.
FDA
Hospira,
Jun 21
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# FDA Approves Hospira's Lidocaine Hydrochloride and Epinephrine Combination Injection
Hospira, Inc. received FDA approval for its lidocaine hydrochloride and epinephrine infiltra…
FDA
Hospira,
Jun 21
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# FDA Approves Hospira's Lidocaine Hydrochloride and Epinephrine for Epidural Use
Hospira, Inc. has received FDA approval for its lidocaine hydrochloride and epinephrine formulati…
FDA
Hospira,
Jun 21
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Hospira, Inc. confirmed the FDA's approval of its ANDA for LidoCaine Hydrochloride and Epinephrine intended for epidural administration, a product launch that is expected to expand…
FDA
Harrow
Dec 31
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# FDA Approves Harrow Eye's IOPIDINE (Apraclonidine Hydrochloride) for Ophthalmic Use
Harrow Eye, LLC has received FDA approval for IOPIDINE 1% (apraclonidine hydrochloride ophtha…