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FDA · 14,507 results Live
FDA TerSera Dec 29 — 0.00

FDA Approves ZOLADEX — TerSera Therapeutics LLC

# 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 — 0.00

FDA Approves DEPAKOTE SPRINKLES — AbbVie Inc.

# 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 — 0.00

FDA Approves Unknown Drug — PFIZER

# 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 Strides Sep 30 — 0.00

FDA Approves ACETAMINOPHEN AND CODEINE PHOSPHATE — Strides Pharma Science Limited

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 — 0.00

FDA Approves ACETAMINOPHEN AND CODEINE PHOSPHATE — Strides Pharma Science Limited

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 — 0.00

FDA Approves Unknown Drug — ALMAJECT

The FDA approved Unknown Drug from ALMAJECT under application ANDA062943 on 1988-09-29.

FDA Hospira, Jun 21 — 0.00

FDA Approves LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE — Hospira, Inc.

# 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 — 0.00

FDA Approves LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE — Hospira, Inc.

# 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 — 0.00

FDA Approves LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE — Hospira, Inc.

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 — 0.00

FDA Approves IOPIDINE 1% — Harrow Eye, LLC

# FDA Approves Harrow Eye's IOPIDINE (Apraclonidine Hydrochloride) for Ophthalmic Use Harrow Eye, LLC has received FDA approval for IOPIDINE 1% (apraclonidine hydrochloride ophtha…

FDA Viatris Dec 22 — 0.00

FDA Approves EPIPEN — Viatris Specialty LLC

Viatris Specialty LLC secured FDA approval for its epinephrine injectable product, expanding the availability of generic alternatives to the branded EpiPen. This regulatory clearan…

FDA ALMAJECT Jul 24 — 0.00

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 and compete against branded com…

FDA ORGANON May 6 — 0.00

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 name from the past, but the data…

FDA Apotex Mar 25 — 0.00

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 formulation (ANDA071258) on Marc…

FDA HIKMA Dec 3 — 0.00

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 positions the company to capture…

FDA Methapharm Oct 31 — 0.00

FDA Approves PROVOCHOLINE — Methapharm Inc.

# FDA Approves Methapharm Inc.'s PROVOCHOLINE for Respiratory Testing Methapharm Inc. received FDA approval for PROVOCHOLINE (methacholine chloride), an inhaled diagnostic agent u…

FDA AMICI Jul 16 — 0.00

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 (ANDA070772), expanding the competitiv…

FDA STRIDES Apr 7 — 0.00

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, 1986, expanding its portfoli…

FDA Hikma Dec 16 — 0.00

FDA Approves DIAZEPAM — Hikma Pharmaceuticals USA Inc.

# FDA Approves Hikma Pharmaceuticals' Intramuscular Diazepam Formulation Hikma Pharmaceuticals USA Inc. has received FDA approval for an intramuscular formulation of diazepam, exp…

FDA Hospira, Sep 13 — 0.00

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 epinephrine as an epidural anesthet…