LYMPHAZURIN

FDA-2023-P-4328

Lachman Consulting Services, Inc. filed a petition regarding the package insert for Lymphazurin, requesting that the FDA evaluate the suitability of the product's labeling. The specific regulatory mechanism and detailed requested action are not explicitly stated in the provided text.

FDA-2023-P-4328

Lachman Consulting Services, Inc. submitted a citizen petition requesting FDA approval of a proposed package insert for Isosulfan Blue Injection as part of a suitability petition, likely to establish the drug's suitability for a particular regulatory pathway or to update labeling information for thi

FDA-2023-P-4328

Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an ANDA for Isosulfan Blue Injection, 1%, 3 mL prefilled syringe, a new strength product based on the reference listed drug LYMPHAZURIN (Isosulfan Blue), 1%, 5

FDA-2023-P-4328

Lachman Consulting Services, Inc. filed a petition requesting that the FDA list Lymphazurin in the Orange Book as suitable for patent listing or to reconsider its current Orange Book listing status. The petition addresses the regulatory eligibility of Lymphazurin for inclusion in the official listin

FDA-2023-P-4297

Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to declare Isosulfan Blue Injection, 1%, 1 mL prefilled syringe suitable for ANDA submission based on the listed reference drug LYMPHAZURIN

FDA-2023-P-4297

Lachman Consulting Services, Inc. filed a citizen petition proposing a draft package insert for isosulfan blue injection in a 1 percent, 1 milliliter prefilled syringe formulation as part of a suitability petition to the FDA.

FDA-2023-P-4297

Lachman Consulting Services, Inc. filed a suitability petition regarding LYMPHAZURIN, a radiopharmaceutical product, requesting FDA assessment of the drug's suitability for a specific regulatory pathway or use.