Methscopolamine Oral Tablet

Brand(s)
Pamine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. (2013-01-28)
Oldest Current Product
1953-04-09
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\METHSCOPOLAMINE
FDAOB
ORAL\TABLET\METHSCOPOLAMINE BROMIDE
SPL Active
ORAL\TABLET\METHSCOPOLAMINE BROMIDE
SPL Moiety
ORAL\TABLET\METHSCOPOLAMINE

product(s) by strength(s)

methscopolamine 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1103370061PamineNDAPharmaderm A Division Of Fougera Pharmaceuticals Inc.1953-04-09METHSCOPOLAMINE BROMIDEORALTABLETNDA0088482981e734-2a20-4b45-8521-8c13ff2b6578

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680482NDA AUTHORIZED GENERICE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2011-03-16METHSCOPOLAMINE BROMIDEORALTABLETNDA0088489607b733-0f3a-4a2c-8057-41d0a5df070d
2519910191ANDABreckenridge Pharmaceutical, Inc.2012-05-21METHSCOPOLAMINE BROMIDEORALTABLETANDA040642157c1cce-bceb-4c74-8aa0-d2be9952d8f9
3643760603ANDABoca Pharmacal, Llc2006-12-28METHSCOPOLAMINE BROMIDEORALTABLETANDA040624e47e9e66-80f3-4b09-afa0-2c19c4dbd594
4763850100ANDABayshore Pharmaceuticals Llc2013-10-01METHSCOPOLAMINE BROMIDEORALTABLETANDA2006025c74bfb0-c80a-4a86-acd1-1e3a1b20255d

methscopolamine 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680483NDA AUTHORIZED GENERICE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2011-07-27METHSCOPOLAMINE BROMIDEORALTABLETNDA0088489607b733-0f3a-4a2c-8057-41d0a5df070d
2519910192ANDABreckenridge Pharmaceutical, Inc.2012-05-21METHSCOPOLAMINE BROMIDEORALTABLETANDA040642157c1cce-bceb-4c74-8aa0-d2be9952d8f9
3643760604ANDABoca Pharmacal, Llc2006-12-28METHSCOPOLAMINE BROMIDEORALTABLETANDA040624e47e9e66-80f3-4b09-afa0-2c19c4dbd594
4763850101ANDABayshore Pharmaceuticals Llc2013-10-01METHSCOPOLAMINE BROMIDEORALTABLETANDA2006025c74bfb0-c80a-4a86-acd1-1e3a1b20255d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290251ANDAGolden State Medical Supply, Inc.2006-12-28METHSCOPOLAMINE BROMIDEORALTABLET643760604ANDA04062446e661aa-b1bd-465e-a800-03bd3455d7d1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040624METHSCOPOLAMINE BROMIDEVINTAGE PHARMACEUTICALS2006-12-28ANDA040624_001, ANDA040624_002
2ANDA040642METHSCOPOLAMINE BROMIDEBRECKENRIDGE PHARMACEUTICAL INC2011-12-06ANDA040642_001, ANDA040642_002
3ANDA080970METHSCOPOLAMINE BROMIDETruePRIVATE FORMULATIONS INCANDA080970_001
4ANDA200602METHSCOPOLAMINE BROMIDEBAYSHORE PHARMACEUTICALS LLC2012-09-24ANDA200602_001, ANDA200602_002
5NDA008848PAMINEFOUGERA PHARMACEUTICALS INCNDA008848_001, NDA008848_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040624_001RXMETHSCOPOLAMINE BROMIDE (2.5MG)ORALTABLETFalseAA2006-12-28METHSCOPOLAMINE BROMIDE
2ANDA040624_002RXMETHSCOPOLAMINE BROMIDE (5MG)ORALTABLETFalseAA2006-12-28METHSCOPOLAMINE BROMIDE
3ANDA040642_001RXMETHSCOPOLAMINE BROMIDE (2.5MG)ORALTABLETFalseAA2011-12-06METHSCOPOLAMINE BROMIDE
4ANDA040642_002RXMETHSCOPOLAMINE BROMIDE (5MG)ORALTABLETFalseAA2011-12-06METHSCOPOLAMINE BROMIDE
5ANDA080970_001discontinuedMETHSCOPOLAMINE BROMIDE (2.5MG)ORALTABLETFalseMETHSCOPOLAMINE BROMIDE
6ANDA200602_001RXMETHSCOPOLAMINE BROMIDE (2.5MG)ORALTABLETFalseAA2012-09-24METHSCOPOLAMINE BROMIDE
7ANDA200602_002RXMETHSCOPOLAMINE BROMIDE (5MG)ORALTABLETFalseAA2012-09-24METHSCOPOLAMINE BROMIDE
8NDA008848_001RXMETHSCOPOLAMINE BROMIDE (2.5MG)ORALTABLETTrueAAPAMINE
9NDA008848_002RXMETHSCOPOLAMINE BROMIDE (5MG)ORALTABLETTrueAA2003-03-25PAMINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1157c1cce-bceb-4c74-8aa0-d2be9952d8f9 (view SPL)Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mgprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2012-05-211519910191, 519910192
22981e734-2a20-4b45-8521-8c13ff2b6578 (view SPL)Pamine 2.5 mg/Pamine Forte 5 mgprescriptionHuman PrescriptionPharmaderm A Division Of Fougera Pharmaceuticals Inc.2012-09-193103370061, 103370062
346e661aa-b1bd-465e-a800-03bd3455d7d1 (view SPL)Methscopolamine Bromide Tablets USP, 2.5 mg Methscopolamine Bromide Tablets USP, 5 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290251
45c74bfb0-c80a-4a86-acd1-1e3a1b20255d (view SPL)Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg Bayshore Pharmaceuticals LLCprescriptionHuman PrescriptionBayshore Pharmaceuticals LlcMANUFACTURE2013-10-282763850100, 763850101
59607b733-0f3a-4a2c-8057-41d0a5df070d (view SPL)Methscopolamine Bromide 2.5 mg TabletsMethscopolamine Bromide 5 mg TabletsprescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2013-01-285001680482, 001680483
6e47e9e66-80f3-4b09-afa0-2c19c4dbd594 (view SPL)Rx OnlyprescriptionHuman PrescriptionBoca Pharmacal, Llc2013-09-122643760603, 643760604

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