Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
#Tentative Approval ×
Regulatorische Updates
27. Sept. 2026•1 Min. Lesezeit
Teva Pharm's Ribavirin Oral Solution Receives Tentative FDA Approval (ANDA 077611)
The FDA granted a tentative approval for Teva Pharm's ribavirin oral solution (40 mg/mL) under ANDA 077611.
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
Sandoz Secures Tentative FDA Approval for Generic Rosiglitazone Maleate Tablets (ANDA078674)
Sandoz's ANDA078674 for oral rosiglitazone maleate tablets (2 mg, 4 mg, 8 mg) has received tentative approval from the FDA as of March 9 2009.
Regulatorische Updates
22. Sept. 2026•1 Min. Lesezeit
FDA Issues Tentative Approval for Atomoxetine Hydrochloride Capsules (ANDA078940)
The FDA has granted tentative approval for six oral capsule strengths of atomoxetine hydrochloride under ANDA078940, sponsored by Actavis Elizabeth.
Regulatorische Updates
18. Sept. 2026•1 Min. Lesezeit
FDA Grants Tentative Approval for Dapagliflozin Tablets (ANDA219408)
Sciegen Pharmaceuticals received tentative FDA approval for 5 mg and 10 mg dapagliflozin tablets under ANDA219408.
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Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
Sandoz Receives FDA Tentative Approval for Epinastine Hydrochloride Ophthalmic Solution (ANDA090950)
Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.
Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
FDA Tentative Approval for Reddys Escitalopram Oxalate Tablets
The FDA granted a Tentative Approval for Dr Reddys Labs' ANDA 077798, covering oral tablets of Escitalopram Oxalate in 5 mg, 10 mg, and 20 mg strengths.
Regulatorische Updates
9. Sept. 2026•1 Min. Lesezeit
FDA Tentative Approval for Tolterodine Oral Tablets (ANDA 076953)
Ranbaxy received a tentative FDA approval for two oral tablet strengths of Tolterodine tartrate (1 mg and 2 mg) under ANDA 076953.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
Cipla’s ABACAVIR SULFATE Oral Solution Receives Tentative FDA Approval (ANDA 078348)
The FDA has granted a tentative approval for Cipla Limited’s ABACAVIR SULFATE oral solution (20 mg) under ANDA 078348.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
CARACO Receives Tentative FDA Approval for Escitalopram (ANDA078219)
CARACO's ANDA078219 for oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) has been granted tentative approval by the FDA.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
Cipla Efavirenz 600mg Tablet Gets FDA Tentative Approval (ANDA 077916)
Cipla Limited’s generic efavirenz 600 mg tablet has been granted tentative approval by the FDA under ANDA 077916.
Regulatorische Updates
24. Aug. 2026•1 Min. Lesezeit
Hikma Pharm's Rosiglitazone Maleate Tablet ANDA Receives Tentative Approval (ANDA078658)
FDA granted tentative approval to Hikma Pharm's ANDA078658 for three oral rosiglitazone maleate tablet strengths (2 mg, 4 mg, 8 mg).