Lorazepam Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paddock Laboratories, Llc (2014-05-29)
Oldest Current Product
1991-06-28
License(s)
ANDA
RxNORM
ORAL SOLUTION\LORAZEPAM
FDAOB
ORAL\CONCENTRATE\LORAZEPAM
ORAL\SOLUTION\LOPERAMIDE HYDROCHLORIDE
ORAL\SUSPENSION\LOPERAMIDE HYDROCHLORIDE
SPL Active
ORAL\CONCENTRATE\LORAZEPAM
ORAL\LIQUID\LORAZEPAM
ORAL\SOLUTION, CONCENTRATE\LORAZEPAM
SPL Moiety
ORAL\CONCENTRATE\LORAZEPAM
ORAL\LIQUID\LORAZEPAM
ORAL\SOLUTION, CONCENTRATE\LORAZEPAM

product(s) by strength(s)

lorazepam 2 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543532ANDARoxane Laboratories, Inc1991-06-28LORAZEPAMORALSOLUTION, CONCENTRATEANDA0730795ff82103-cc57-4af9-9362-82a7c686271d
2001210770ANDAPharmaceutical Associates, Inc.2010-11-01LORAZEPAMORALLIQUIDANDA090260711b60a3-028d-41d4-aa17-8f976e6df23e
3005740163ANDAPaddock Laboratories, Llc2009-04-01LORAZEPAMORALSOLUTION, CONCENTRATEANDA07924489e39a69-b5d7-4de4-8114-f63149a19931
4503830705ANDAHi-Tech Pharmacal Co., Inc.2012-01-30LORAZEPAMORALCONCENTRATEANDA20016973bfaeab-94db-48c2-a194-8b173025de78
5651620687ANDAAmneal Pharmaceuticals2010-02-01LORAZEPAMORALCONCENTRATEANDA091383bf265c2e-ab2f-42e5-96cf-3998eb5a644d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686010ANDAPhysicians Total Care, Inc.2009-03-31LORAZEPAMORALSOLUTION, CONCENTRATE000543532ANDA073079ee9e95a6-a9d7-43c1-ac3c-c9dc4b390760

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA072755LORAZEPAM INTENSOLROXANE LABORATORIES INC1991-06-28ANDA072755_001
2ANDA073062LOPERAMIDE HYDROCHLORIDETrueWATSON LABORATORIES INC1993-05-28ANDA073062_001Loperamide Oral Solution
Loperamide Oral Suspension
3ANDA073079LOPERAMIDE HYDROCHLORIDEROXANE LABORATORIES INC1992-04-30ANDA073079_001Loperamide Oral Solution
Loperamide Oral Suspension
4ANDA073187LOPERAMIDE HYDROCHLORIDETrueALPHARMA US PHARMACEUTICALS DIVISION1992-09-15ANDA073187_001Loperamide Oral Solution
Loperamide Oral Suspension
5ANDA073243LOPERAMIDE HYDROCHLORIDEL PERRIGO CO1992-01-21ANDA073243_001Loperamide Oral Solution
Loperamide Oral Suspension
6ANDA073478LOPERAMIDE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1995-06-23ANDA073478_001Loperamide Oral Solution
Loperamide Oral Suspension
7ANDA074352LOPERAMIDE HYDROCHLORIDEHI TECH PHARMACAL CO INC1995-11-17ANDA074352_001Loperamide Oral Solution
Loperamide Oral Suspension
8ANDA074730LOPERAMIDE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG1997-08-28ANDA074730_001Loperamide Oral Solution
Loperamide Oral Suspension
9ANDA074991LOPERAMIDE HYDROCHLORIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1997-12-29ANDA074991_001Loperamide Oral Solution
Loperamide Oral Suspension
10ANDA079244LORAZEPAMPADDOCK LABORATORIES LLC2009-04-28ANDA079244_001
11ANDA090260LORAZEPAMPHARMACEUTICAL ASSOC INC2010-06-15ANDA090260_001
12ANDA091383LORAZEPAMAMNEAL PHARMACEUTICALS2009-12-23ANDA091383_001
13ANDA091407LORAZEPAMLUPIN LTD2013-02-19ANDA091407_001
14ANDA200169LORAZEPAMHI-TECH PHARMACAL CO INC2012-01-30ANDA200169_001
15NDA019037IMODIUMTrueJANSSEN PHARMACEUTICALS INC1984-07-31NDA019037_001Loperamide Oral Solution
Loperamide Oral Suspension
16NDA019487IMODIUM A-DJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1988-03-01NDA019487_001, NDA019487_002Loperamide Oral Solution
Loperamide Oral Suspension

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072755_001RXLORAZEPAM (2MG/ML)ORALCONCENTRATETrueAA1991-06-28LORAZEPAM INTENSOL
2ANDA073062_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1993-05-28LOPERAMIDE HYDROCHLORIDE
3ANDA073079_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-04-30LOPERAMIDE HYDROCHLORIDE
4ANDA073187_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-09-15LOPERAMIDE HYDROCHLORIDE
5ANDA073243_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-01-21LOPERAMIDE HYDROCHLORIDE
6ANDA073478_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1995-06-23LOPERAMIDE HYDROCHLORIDE
7ANDA074352_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1995-11-17LOPERAMIDE HYDROCHLORIDE
8ANDA074730_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1997-08-28LOPERAMIDE HYDROCHLORIDE
9ANDA074991_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1997-12-29LOPERAMIDE HYDROCHLORIDE
10ANDA079244_001RXLORAZEPAM (2MG/ML)ORALCONCENTRATEFalseAA2009-04-28LORAZEPAM
11ANDA090260_001RXLORAZEPAM (2MG/ML)ORALCONCENTRATEFalseAA2010-06-15LORAZEPAM
12ANDA091383_001RXLORAZEPAM (2MG/ML)ORALCONCENTRATEFalseAA2009-12-23LORAZEPAM
13ANDA091407_001RXLORAZEPAM (2MG/ML)ORALCONCENTRATEFalseAA2013-02-19LORAZEPAM
14ANDA200169_001RXLORAZEPAM (2MG/ML)ORALCONCENTRATEFalseAA2012-01-30LORAZEPAM
15NDA019037_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1984-07-31IMODIUM
16NDA019487_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONTrue1988-03-01IMODIUM A-D
17NDA019487_002OTCLOPERAMIDE HYDROCHLORIDE (1MG/7.5ML)ORALSUSPENSIONTrue2004-07-08IMODIUM A-D

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15ff82103-cc57-4af9-9362-82a7c686271d (view SPL)LORAZEPAM INTENSOL Oral Concentrate USP2 mg per mLprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-10-195000543532
2711b60a3-028d-41d4-aa17-8f976e6df23e (view SPL)LORAZEPAM Oral Concentrate USP CIVprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2010-12-024001210770
373bfaeab-94db-48c2-a194-8b173025de78 (view SPL)Lorazepam Oral Concentrate, USP CIVprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2012-01-304503830705
489e39a69-b5d7-4de4-8114-f63149a19931 (view SPL)Lorazepam Oral Concentrate, USPprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-05-292005740163
5bf265c2e-ab2f-42e5-96cf-3998eb5a644d (view SPL)Lorazepam Oral Concentrate USP,prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2010-02-011651620687
6ee9e95a6-a9d7-43c1-ac3c-c9dc4b390760 (view SPL)LORAZEPAM INTENSOL Oral Concentrate USP2 mg per mLprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-11-182548686010

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII