Sun Pharma — Pharmaceutical Intelligence | Humanexa Signals

RegulatoryAugust 3, 2026

FDA Accepts Supplement for Leuprolide Acetate by Sun Pharma

The FDA has accepted a supplemental application for Leuprolide Acetate submitted by Sun Pharma.

RegulatoryAugust 3, 2026

FDA Grants Approval for Valproic Acid Supplement by Sun Pharma

The FDA has granted approval for the supplemental application ANDA091037 for Valproic Acid submitted by Sun Pharma.

RegulatoryAugust 2, 2026

FDA Accepts Supplement for Metformin Hydrochloride by Sun Pharma

The FDA has accepted a supplemental application for Metformin Hydrochloride submitted by Sun Pharma.

RegulatoryAugust 1, 2026

FDA Accepts Supplement for Finasteride by Sun Pharma

The FDA has accepted a supplemental application for Finasteride (ANDA090508) submitted by Sun Pharma.

RegulatoryJuly 31, 2026

FDA Approves Doxepin Hydrochloride Application by Sun Pharma

The FDA has approved the application ANDA213919 for Doxepin Hydrochloride submitted by Sun Pharma.

RegulatoryJuly 31, 2026

FDA Approves Lenalidomide Supplement Application by Sun Pharma

The FDA has approved the supplemental application ANDA211846 for lenalidomide submitted by Sun Pharma.

RegulatoryJuly 23, 2026

FDA Accepts Supplement for Rosuvastatin Calcium by Sun Pharma

The FDA has accepted a supplemental application for Rosuvastatin Calcium submitted by Sun Pharma.

RegulatoryJuly 23, 2026

FDA Accepts Supplement for ILUMYA (Tildrakizumab) by Sun Pharma

The FDA has accepted a supplemental biologics application for ILUMYA (tildrakizumab) from Sun Pharma.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Methotrexate Sodium ANDA201749 by Sun Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Methotrexate Sodium submitted by Sun Pharma.

RegulatoryJuly 20, 2026

FDA Accepts Supplemental Application for Dapagliflozin and Metformin Hydrochloride

The FDA has accepted a supplemental application for dapagliflozin and metformin hydrochloride submitted by Sun Pharma.

RegulatoryJuly 16, 2026

FDA Accepts Supplemental NDA for YONSA by Sun Pharma

The FDA has accepted a supplemental NDA for YONSA, which contains abiraterone acetate as the active ingredient.

RegulatoryJuly 13, 2026

FDA Grants AP Status for Leuprolide Acetate ANDA078885 by Sun Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Leuprolide Acetate submitted by Sun Pharma.

RegulatoryJuly 12, 2026

FDA Grants AP Status for Valproic Acid ANDA091037 by Sun Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Valproic Acid submitted by Sun Pharma.

RegulatoryJuly 11, 2026

FDA Accepts Supplement Application for Finasteride by Sun Pharma

The FDA has accepted a supplemental application for Finasteride submitted by Sun Pharma.

RegulatoryJuly 9, 2026

FDA Accepts Supplement for LEQSELVI (Deuruxolitinib Phosphate) by Sun Pharma

The FDA has accepted a supplemental application for LEQSELVI, an investigational treatment containing Deuruxolitinib Phosphate.

RegulatoryJuly 1, 2026

FDA Approves Fluocinolone Acetonide Supplement by Sun Pharma

The FDA has approved a supplemental application for Fluocinolone Acetonide submitted by Sun Pharma.

RegulatoryJune 29, 2026

FDA Approval for Oxycodone Hydrochloride Supplement by Sun Pharma

The FDA has approved a supplement for Oxycodone Hydrochloride submitted by Sun Pharma.

RegulatoryJune 29, 2026

FDA Approval Letter for Tramadol Hydrochloride by Sun Pharma

The FDA has issued an approval letter for the ANDA076100 application for Tramadol Hydrochloride submitted by Sun Pharma.

RegulatoryJune 26, 2026

FDA Accepts Supplement Application for SYNALGOS-DC by Sun Pharma

The FDA has accepted a supplemental application for SYNALGOS-DC, a combination analgesic.

RegulatoryJune 26, 2026

FDA Approves Supplemental NDA for SYNALGOS-DC by Sun Pharma

The FDA has approved a supplemental NDA for SYNALGOS-DC, which contains aspirin, caffeine, and dihydrocodeine bitartrate.

RegulatoryJune 24, 2026

FDA Approval for Methadone Hydrochloride by Sun Pharma

The FDA has approved the supplemental application ANDA208305 for Methadone Hydrochloride submitted by Sun Pharma.

RegulatoryJune 24, 2026

FDA Approval Letter for Oxycodone and Aspirin Combination

The FDA has issued an approval letter for ANDA040260 concerning a combination of oxycodone and aspirin.

RegulatoryJune 24, 2026

FDA Approval for Tramadol Hydrochloride Supplement by Sun Pharma

The FDA has approved a supplement application for Tramadol Hydrochloride submitted by Sun Pharma.

RegulatoryJune 20, 2026

FDA Accepts ANDA for Dextromethorphan Hydrobromide and Quinidine Sulfate by Sun Pharma

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Dextromethorphan Hydrobromide and Quinidine Sulfate submitted by Sun Pharma.

RegulatoryJune 20, 2026

FDA Accepts Supplement Application for Absorica by Sun Pharma

The FDA has accepted a supplemental application for Absorica, an isotretinoin product from Sun Pharma.

RegulatoryJune 18, 2026

FDA Accepts Supplement for ABSORICA LD by Sun Pharma

The FDA has accepted a supplemental application for ABSORICA LD, an isotretinoin product by Sun Pharma.

Recent signals(31)

FDA Accepts Supplement for Leuprolide Acetate by Sun Pharma

FDA Grants Approval for Valproic Acid Supplement by Sun Pharma

FDA Accepts Supplement for Metformin Hydrochloride by Sun Pharma

FDA Grants Approval for Sugammadex Sodium ANDA214319 by Sun Pharma

FDA Accepts Supplement for Finasteride by Sun Pharma

FDA Approves Doxepin Hydrochloride Application by Sun Pharma

FDA Approves Lenalidomide Supplement Application by Sun Pharma

FDA Accepts Supplement for Rosuvastatin Calcium by Sun Pharma

FDA Accepts Supplement for ILUMYA (Tildrakizumab) by Sun Pharma

FDA Approves ANDA for Tofacitinib Citrate by Sun Pharma

FDA Grants AP Status for Methotrexate Sodium ANDA201749 by Sun Pharma

FDA Accepts Supplemental Application for Dapagliflozin and Metformin Hydrochloride

FDA Accepts Supplemental NDA for YONSA by Sun Pharma

FDA Grants AP Status for Leuprolide Acetate ANDA078885 by Sun Pharma

FDA Grants AP Status for Valproic Acid ANDA091037 by Sun Pharma

FDA Accepts Supplement Application for Finasteride by Sun Pharma

FDA Accepts Supplement for LEQSELVI (Deuruxolitinib Phosphate) by Sun Pharma

FDA Grants Approval for Doxepin Hydrochloride ANDA213919 by Sun Pharma

Sun Pharma initiates trial for deuruxolitinib in severe alopecia areata in Japan

FDA Approves Fluocinolone Acetonide Supplement by Sun Pharma

FDA Approval for Oxycodone Hydrochloride Supplement by Sun Pharma

FDA Approval Letter for Tramadol Hydrochloride by Sun Pharma

FDA Grants AP Status for Levorphanol Tartrate ANDA213906 by Sun Pharma

FDA Accepts Supplement Application for SYNALGOS-DC by Sun Pharma

FDA Approves Supplemental NDA for SYNALGOS-DC by Sun Pharma

FDA Approval for Methadone Hydrochloride by Sun Pharma

FDA Approval Letter for Oxycodone and Aspirin Combination

FDA Approval for Tramadol Hydrochloride Supplement by Sun Pharma

FDA Accepts ANDA for Dextromethorphan Hydrobromide and Quinidine Sulfate by Sun Pharma

FDA Accepts Supplement Application for Absorica by Sun Pharma

FDA Accepts Supplement for ABSORICA LD by Sun Pharma

Upcoming catalysts

Regulatory activity(26)

FDA Accepts Supplement for Leuprolide Acetate by Sun Pharma

FDA Grants Approval for Valproic Acid Supplement by Sun Pharma

FDA Accepts Supplement for Metformin Hydrochloride by Sun Pharma

FDA Accepts Supplement for Finasteride by Sun Pharma

FDA Approves Doxepin Hydrochloride Application by Sun Pharma

FDA Approves Lenalidomide Supplement Application by Sun Pharma

FDA Accepts Supplement for Rosuvastatin Calcium by Sun Pharma

FDA Accepts Supplement for ILUMYA (Tildrakizumab) by Sun Pharma

FDA Grants AP Status for Methotrexate Sodium ANDA201749 by Sun Pharma

FDA Accepts Supplemental Application for Dapagliflozin and Metformin Hydrochloride

FDA Accepts Supplemental NDA for YONSA by Sun Pharma

FDA Grants AP Status for Leuprolide Acetate ANDA078885 by Sun Pharma

FDA Grants AP Status for Valproic Acid ANDA091037 by Sun Pharma

FDA Accepts Supplement Application for Finasteride by Sun Pharma

FDA Accepts Supplement for LEQSELVI (Deuruxolitinib Phosphate) by Sun Pharma

FDA Approves Fluocinolone Acetonide Supplement by Sun Pharma

FDA Approval for Oxycodone Hydrochloride Supplement by Sun Pharma

FDA Approval Letter for Tramadol Hydrochloride by Sun Pharma

FDA Accepts Supplement Application for SYNALGOS-DC by Sun Pharma

FDA Approves Supplemental NDA for SYNALGOS-DC by Sun Pharma

FDA Approval for Methadone Hydrochloride by Sun Pharma

FDA Approval Letter for Oxycodone and Aspirin Combination

FDA Approval for Tramadol Hydrochloride Supplement by Sun Pharma

FDA Accepts ANDA for Dextromethorphan Hydrobromide and Quinidine Sulfate by Sun Pharma

FDA Accepts Supplement Application for Absorica by Sun Pharma

FDA Accepts Supplement for ABSORICA LD by Sun Pharma

Clinical activity(1)

Sun Pharma initiates trial for deuruxolitinib in severe alopecia areata in Japan

Competitive activity(1)

FDA Grants Approval for Sugammadex Sodium ANDA214319 by Sun Pharma

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Indications

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