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    About

    Omnivium Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of difficult-to-make products. It focuses on developing difficult generic and 505(b)(2) products. Through our strong domestic and global partnerships, products will include both patented and off-patented brands and generics.

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    Omnivium PharmaceuticalsUnited_States_of_America Flag
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    U.S.A
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    2131 Felver Court, Suite A, Rahway, New Jersey 07065
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    enquiries@pharmacompass.com
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    https://omniviumpharma.com/
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    Omnivium Pharms’ Generics Olanzapine Receives Approval in US
    Omnivium Pharms’ Generics Olanzapine Receives Approval in US

    23 Jan 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219048

    FDA
    23 Jan 2026
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    Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures

    Details:

    Numbrino (Cocaine HCl) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Anesthesia, Local.


    Lead Product(s): Cocaine Hydrochloride

    Therapeutic Area: Neurology Brand Name: Numbrino

    Study Phase: Phase IIIProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 17, 2025

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    Lead Product(s) : Cocaine Hydrochloride

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures

    Details : Numbrino (Cocaine HCl) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Anesthesia, Local.

    Product Name : Numbrino

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    December 17, 2025

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    Brand Name : CLEMASTINE FUMARATE

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    Regulatory Info : DISCN

    Registration Country : USA

    CLEMASTINE FUMARATE

    Omnivium Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : CLEMASTINE FUMARATE

    Dosage Strength : 2.68MG

    Packaging :

    Approval Date : 1993-10-31

    Application Number : 73459

    Regulatory Info : DISCN

    Registration Country : USA

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    Brand Name : NUMBRINO

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    Regulatory Info : RX

    Registration Country : USA

    COCAINE HYDROCHLORIDE

    Omnivium Pharmaceuticals

    Dosage Form : SOLUTION;NASAL

    Brand Name : NUMBRINO

    Dosage Strength : 4%

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    Approval Date : 2020-01-10

    Application Number : 209575

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

    Registration Country : USA

    GLYCOPYRROLATE

    Omnivium Pharmaceuticals

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : GLYCOPYRROLATE

    Dosage Strength : 0.2MG/ML

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    Approval Date : 2022-11-29

    Application Number : 212871

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

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    ISONIAZID

    Omnivium Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : ISONIAZID

    Dosage Strength : 100MG

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    Approval Date : 1997-06-26

    Application Number : 40090

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

    Registration Country : USA

    ISONIAZID

    Omnivium Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : ISONIAZID

    Dosage Strength : 300MG

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    Approval Date : 1997-06-26

    Application Number : 40090

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : MONOKET

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    Regulatory Info : RX

    Registration Country : USA

    ISOSORBIDE MONONITRATE

    Omnivium Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : MONOKET

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 1993-06-30

    Application Number : 20215

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : MONOKET

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    Regulatory Info : RX

    Registration Country : USA

    ISOSORBIDE MONONITRATE

    Omnivium Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : MONOKET

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 1993-06-30

    Application Number : 20215

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : OLANZAPINE

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    Regulatory Info : RX

    Registration Country : USA

    OLANZAPINE

    Omnivium Pharmaceuticals

    Dosage Form : POWDER;INTRAMUSCULAR

    Brand Name : OLANZAPINE

    Dosage Strength : 10MG/VIAL

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    Approval Date : 2026-01-23

    Application Number : 219048

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

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    SODIUM BICARBONATE

    Omnivium Pharmaceuticals

    Dosage Form : SOLUTION;INTRAVENOUS

    Brand Name : SODIUM BICARBONATE

    Dosage Strength : 50MEQ/50ML (1MEQ/ML)

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    Approval Date : 2023-06-15

    Application Number : 216364

    Regulatory Info : RX

    Registration Country : USA

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    RLD : No

    TE Code :

    CLEMASTINE FUMARATE

    Omnivium Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : CLEMASTINE FUMARATE

    Dosage Strength : 2.68MG

    Approval Date : 1993-10-31

    Application Number : 73459

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Brand Name : NUMBRINO

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    RLD : Yes

    TE Code :

    COCAINE HYDROCHLORIDE

    Omnivium Pharmaceuticals

    Dosage Form : SOLUTION; NASAL

    Proprietary Name : NUMBRINO

    Dosage Strength : 4%

    Approval Date : 2020-01-10

    Application Number : 209575

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    RLD : No

    TE Code : AP

    GLYCOPYRROLATE

    Omnivium Pharmaceuticals

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : GLYCOPYRROLATE

    Dosage Strength : 0.2MG/ML

    Approval Date : 2022-11-29

    Application Number : 212871

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code : AA

    ISONIAZID

    Omnivium Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : ISONIAZID

    Dosage Strength : 100MG

    Approval Date : 1997-06-26

    Application Number : 40090

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    RLD : No

    TE Code : AA

    ISONIAZID

    Omnivium Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : ISONIAZID

    Dosage Strength : 300MG

    Approval Date : 1997-06-26

    Application Number : 40090

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    RLD : Yes

    TE Code : AB

    ISOSORBIDE MONONITRATE

    Omnivium Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : MONOKET

    Dosage Strength : 20MG

    Approval Date : 1993-06-30

    Application Number : 20215

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code : AB

    ISOSORBIDE MONONITRATE

    Omnivium Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : MONOKET

    Dosage Strength : 10MG

    Approval Date : 1993-06-30

    Application Number : 20215

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : OLANZAPINE

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    RLD : No

    TE Code : AP

    OLANZAPINE

    Omnivium Pharmaceuticals

    Dosage Form : POWDER; INTRAMUSCULAR

    Proprietary Name : OLANZAPINE

    Dosage Strength : 10MG/VIAL

    Approval Date : 2026-01-23

    Application Number : 219048

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code : AP

    SODIUM BICARBONATE

    Omnivium Pharmaceuticals

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : SODIUM BICARBONATE

    Dosage Strength : 50MEQ/50ML (1MEQ/ML)

    Approval Date : 2023-06-15

    Application Number : 216364

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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