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25 items- FDAFDA Approval for LEVOFLOXACIN issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug LEVOFLOXACIN (SUPPL-11) with active ingredient LEVOFLOXACIN has changed to 'Approval' on 09/20/2024. Application Category: ANDA, Application Number: 205222, Application Classification: Labeling
- FDAFDA Approval for MYCOPHENOLATE MOFETIL issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug MYCOPHENOLATE MOFETIL (SUPPL-7) with active ingredient MYCOPHENOLATE MOFETIL has changed to 'Approval' on 08/13/2024. Application Category: ANDA, Application Number: 214525, Application Classification: REMS
- FDAFDA Approval for SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE (ORIG-1) with active ingredient MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE has changed to 'Approval' on 07/15/2024. Application Category: ANDA, Application Number: 209941, Application Classification:
- FDAFDA Approval for PREDNISOLONE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug PREDNISOLONE (SUPPL-13) with active ingredient PREDNISOLONE has changed to 'Approval' on 06/05/2024. Application Category: ANDA, Application Number: 040775, Application Classification: Labeling
- FDAFDA Approval for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUPPL-17) with active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE has changed to 'Approval' on 03/20/2024. Application Category: ANDA, Application Number: 205022, Application Classification: REMS
- FDAFDA Approval for OXYCODONE AND ACETAMINOPHEN issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug OXYCODONE AND ACETAMINOPHEN (SUPPL-12) with active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 03/13/2024. Application Category: ANDA, Application Number: 207333, Application Classification: Labeling
- FDAFDA Approval for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-4) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 02/27/2024. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling
- FDAFDA Approval for LISDEXAMFETAMINE DIMESYLATE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (SUPPL-1) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 02/14/2024. Application Category: ANDA, Application Number: 215802, Application Classification: Labeling
- FDAFDA Approval for TRIAMTERENE AND HYDROCHLOROTHIAZIDE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug TRIAMTERENE AND HYDROCHLOROTHIAZIDE (SUPPL-12) with active ingredient HYDROCHLOROTHIAZIDE; TRIAMTERENE has changed to 'Approval' on 01/08/2024. Application Category: ANDA, Application Number: 201407, Application Classification: Labeling
- FDAFDA Approval for PRAZOSIN HYDROCHLORIDE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug PRAZOSIN HYDROCHLORIDE (ORIG-1) with active ingredient PRAZOSIN HYDROCHLORIDE has changed to 'Approval' on 01/03/2024. Application Category: ANDA, Application Number: 214083, Application Classification:
- FDAFDA Approval for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUPPL-20) with active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE has changed to 'Approval' on 12/15/2023. Application Category: ANDA, Application Number: 205022, Application Classification: Labeling
- FDAFDA Approval for OXYCODONE AND ACETAMINOPHEN issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug OXYCODONE AND ACETAMINOPHEN (SUPPL-11) with active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 12/15/2023. Application Category: ANDA, Application Number: 207333, Application Classification: Labeling
- FDAFDA Approval for OXYCODONE AND ACETAMINOPHEN issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug OXYCODONE AND ACETAMINOPHEN (SUPPL-10) with active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 12/15/2023. Application Category: ANDA, Application Number: 207333, Application Classification: Labeling
- FDAFDA Approval for HYDROCODONE BITARTRATE AND ACETAMINOPHEN issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-9) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 12/15/2023. Application Category: ANDA, Application Number: 207172, Application Classification: Labeling
- FDAFDA Approval for HYDROCODONE BITARTRATE AND ACETAMINOPHEN issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-9) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 12/15/2023. Application Category: ANDA, Application Number: 207171, Application Classification: Labeling
- NEWSWhy This Lucid Analyst Is Bullish On The EV Maker Despite Q3 DisappointmentPremium electric vehicle manufacturer Lucid Group, Inc. (NASDAQ:LCI) reported below-consensus third-quarter revenue and also lowered its production guidance for 2023. The stock has reacted to the results with a move to the downside. Notwithstanding the subpar results, Needham analyst Chris Pierce reiterated a Buy rating on the stock. He lowered his price target from $9 to $5. Needham’s Bullish Thesis: Pierce premised his optimism regarding Lucid on the company’s “industry-leading” battery and drive-train technology. “We continue… to see legacy OEMs struggle to make affordable EVs, with LCID a willing potential technology partner to drive down costs, particularly on the battery tech side,”
- FDAFDA Approval for RABEPRAZOLE SODIUM issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug RABEPRAZOLE SODIUM (SUPPL-14) with active ingredient RABEPRAZOLE SODIUM has changed to 'Approval' on 11/01/2023. Application Category: ANDA, Application Number: 090678, Application Classification: Labeling
- FDAFDA Approval for RABEPRAZOLE SODIUM issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug RABEPRAZOLE SODIUM (SUPPL-18) with active ingredient RABEPRAZOLE SODIUM has changed to 'Approval' on 11/01/2023. Application Category: ANDA, Application Number: 090678, Application Classification: Labeling
- FDAFDA Approval for RABEPRAZOLE SODIUM issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug RABEPRAZOLE SODIUM (SUPPL-16) with active ingredient RABEPRAZOLE SODIUM has changed to 'Approval' on 11/01/2023. Application Category: ANDA, Application Number: 090678, Application Classification: Labeling
- FDAFDA Approval for RABEPRAZOLE SODIUM issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug RABEPRAZOLE SODIUM (SUPPL-13) with active ingredient RABEPRAZOLE SODIUM has changed to 'Approval' on 11/01/2023. Application Category: ANDA, Application Number: 090678, Application Classification: Labeling
- FDAFDA Approval for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-2) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 10/13/2023. Application Category: ANDA, Application Number: 215565, Application Classification: Labeling
- FDAFDA Approval for PANTOPRAZOLE SODIUM issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug PANTOPRAZOLE SODIUM (SUPPL-34) with active ingredient PANTOPRAZOLE SODIUM has changed to 'Approval' on 09/27/2023. Application Category: ANDA, Application Number: 078281, Application Classification: Labeling
- FDAFDA Approval for LISDEXAMFETAMINE DIMESYLATE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (ORIG-1) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 08/25/2023. Application Category: ANDA, Application Number: 215802, Application Classification:
- FDAFDA Approval for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-1) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 08/24/2023. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling
- FDAFDA Approval for FLUOXETINE HYDROCHLORIDE issued to LANNETT CO INCSubmission status for LANNETT CO INC's drug FLUOXETINE HYDROCHLORIDE (SUPPL-17) with active ingredient FLUOXETINE HYDROCHLORIDE has changed to 'Approval' on 08/18/2023. Application Category: ANDA, Application Number: 077849, Application Classification: Labeling