Spinal Cord Injury
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-12-16FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental abbreviated new drug application for tizanidine hydrochloride (generic tizanidine).
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FDA approval · 2025-11-21FDA Approved: BACLOFEN — Supplemental Application (Medcore LLC)
FDA approved Medcore LLC's supplemental application for Baclofen (ANDA 214099).
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FDA approval · 2025-08-12FDA Approved: TIZANIDINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for tizanidine from Zydus Lifesciences Limited (ANDA208187).
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FDA approval · 2025-06-03FDA Approved: BACLOFEN — Supplemental Application (Advagen Pharma Ltd)
FDA approves a supplemental application for Baclofen from Advagen Pharma Ltd.
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FDA approval · 2025-04-30FDA Approved: PREGABALIN — Supplemental Application (Cipla USA, Inc.)
The FDA approved Cipla's supplemental application to market a generic pregabalin product, enabling a generic version of the drug for its app…
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FDA approval · 2025-03-03FDA Approved: TIZANIDINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for tizanidine submitted by Apotex Corp. This action approves the changes described in the supplemen…
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FDA approval · 2024-12-17FDA Approved: TIZANIDINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application from Apotex Corp. for Tizanidine (generic), authorizing changes to the approved ANDA product.
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FDA approval · 2024-12-12FDA Approved: ONTRALFY — Original Application (Rosemont Pharmaceuticals, LLC)
FDA approved ONTRALFY (tizanidine hydrochloride) under an Original Application by Rosemont Pharmaceuticals, LLC for the management of muscle…
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FDA approval · 2024-12-06FDA Approved: BACLOFEN — Original Application (Advagen Pharma Ltd)
FDA approved Advagen Pharma Ltd's Baclofen Original Application, confirming a generic Baclofen product for approved indications.
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FDA approval · 2024-11-27FDA Approved: TIZANIDINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for tizanidine from Unichem Pharmaceuticals (USA), Inc., approving the generic product with labeling…
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FDA approval · 2024-08-07FDA Approved: TIZANIDINE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for a generic version of tizanidine from Rising Pharma Holdings, Inc., enabling marketing of the drug …
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FDA approval · 2024-04-18FDA Approved: BACLOFEN — Supplemental Application (Wilshire Pharmaceuticals, Inc.)
FDA approves a supplemental application for baclofen from Wilshire Pharmaceuticals, Inc., updating the existing baclofen product.
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FDA approval · 2024-02-05FDA Approved: BACLOFEN — Supplemental Application (TruPharma LLC)
FDA approved TruPharma LLC's supplemental application for baclofen (generic) under the approved regulatory pathway.
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FDA approval · 2023-10-12FDA Approved: BACLOFEN — Supplemental Application (Palmetto Pharmaceuticals Inc.)
FDA approved a supplemental application for baclofen from Palmetto Pharmaceuticals Inc., indicating an update to the drug's existing approva…
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FDA approval · 2023-09-12FDA Approved: BACLOFEN — Supplemental Application (TruPharma LLC)
FDA approved TruPharma LLC's supplemental application for baclofen, enabling a new generic version to be marketed.
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FDA approval · 2023-06-08FDA Approved: BACLOFEN — Original Application (Slayback Pharma LLC)
The FDA approved Slayback Pharma LLC's original application for a generic baclofen product for the treatment of spasticity associated with m…
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FDA approval · 2022-06-10FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
The FDA approved a supplemental application for a generic tizanidine hydrochloride product submitted by Alembic Pharmaceuticals Limited unde…
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FDA approval · 2022-06-10FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Tizanidine Hydrochloride from Aurobindo Pharma Limited under an ANDA. This action confirms regul…
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FDA approval · 2022-05-25FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)
FDA approves a supplemental application for tizanidine hydrochloride submitted by Zydus Lifesciences Limited. This action completes FDA appr…
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FDA approval · 2022-05-25FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)
FDA approved a supplemental application for tizanidine hydrochloride by Nivagen Pharmaceuticals, Inc., representing a regulatory update for …
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FDA approval · 2022-02-04FDA Approved: BACLOFEN — Original Application (Wilshire Pharmaceuticals, Inc.)
The FDA approved an Original Application for baclofen by Wilshire Pharmaceuticals, authorizing its use for treating spasticity.
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FDA approval · 2022-01-25FDA Approved: BACLOFEN — Original Application (Major Pharmaceuticals)
FDA approved a generic baclofen under an Original Application from Major Pharmaceuticals.
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FDA approval · 2021-11-22FDA Approved: LYVISPAH — Original Application (Amneal Pharmaceuticals LLC)
FDA approved LYVISPAH (baclofen) from Amneal Pharmaceuticals LLC as an Original Application. It is indicated for the management of spasticit…
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FDA approval · 2021-09-22FDA Approved: BACLOFEN — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for baclofen from Chartwell RX, LLC, under ANDA077241, indicating regulatory approval of this supple…
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FDA approval · 2021-07-13FDA Approved: BACLOFEN — Original Application (Medcore LLC)
FDA approves Medcore LLC's original ANDA for generic baclofen (oral) for the treatment of spasticity associated with multiple sclerosis and …