Estazolam Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-11-03)
Oldest Current Product
1997-07-14
License(s)
ANDA
RxNORM
ORAL TABLET\ESTAZOLAM
FDAOB
ORAL\TABLET\ESTAZOLAM
SPL Active
ORAL\TABLET\ESTAZOLAM
SPL Moiety
ORAL\TABLET\ESTAZOLAM

product(s) by strength(s)

estazolam 1 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930129ANDATeva Pharmaceuticals Usa Inc1997-07-14ESTAZOLAMORALTABLETANDA07492150914a46-eab6-4c83-97cf-6ab0234c8126
2005910744ANDAWatson Laboratories, Inc.1997-08-19ESTAZOLAMORALTABLETANDA074818a1e3b4bf-22e9-430a-a768-4d86ae886c9e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290566ANDAGolden State Medical Supply, Inc.1997-08-19ESTAZOLAMORALTABLET005910744ANDA0748182fb7763f-6ce4-43b9-b3be-90a66315828b

estazolam 2 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930130ANDATeva Pharmaceuticals Usa Inc1997-07-14ESTAZOLAMORALTABLETANDA07492150914a46-eab6-4c83-97cf-6ab0234c8126
2005910745ANDAWatson Laboratories, Inc.1997-08-19ESTAZOLAMORALTABLETANDA074818a1e3b4bf-22e9-430a-a768-4d86ae886c9e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950220ANDARebel Distributors Corp1997-08-19ESTAZOLAMORALTABLET005910745ANDA0748183607bed9-64f3-4b14-9b4d-7cc70dc8b185
2604290567ANDAGolden State Medical Supply, Inc.1997-08-19ESTAZOLAMORALTABLET005910745ANDA0748182fb7763f-6ce4-43b9-b3be-90a66315828b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074818ESTAZOLAMWATSON LABORATORIES INC1997-08-19ANDA074818_001, ANDA074818_002
2ANDA074826ESTAZOLAMPAR PHARMACEUTICAL INC1997-07-03ANDA074826_001, ANDA074826_002
3ANDA074921ESTAZOLAMTEVA PHARMACEUTICALS USA INC1997-07-10ANDA074921_001, ANDA074921_002
4NDA019080PROSOMTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV1990-12-26NDA019080_001, NDA019080_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074818_001RXESTAZOLAM (1MG)ORALTABLETFalseAB1997-08-19ESTAZOLAM
2ANDA074818_002RXESTAZOLAM (2MG)ORALTABLETFalseAB1997-08-19ESTAZOLAM
3ANDA074826_001RXESTAZOLAM (1MG)ORALTABLETFalseAB1997-07-03ESTAZOLAM
4ANDA074826_002RXESTAZOLAM (2MG)ORALTABLETFalseAB1997-07-03ESTAZOLAM
5ANDA074921_001RXESTAZOLAM (1MG)ORALTABLETFalseAB1997-07-10ESTAZOLAM
6ANDA074921_002RXESTAZOLAM (2MG)ORALTABLETTrueAB1997-07-10ESTAZOLAM
7NDA019080_001discontinuedESTAZOLAM (1MG)ORALTABLETFalse1990-12-26PROSOM
8NDA019080_002discontinuedESTAZOLAM (2MG)ORALTABLETFalse1990-12-26PROSOM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12fb7763f-6ce4-43b9-b3be-90a66315828b (view SPL)Estazolam Tablets, USP CIV Revised: September 2008 Rx only 14444-2prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290566, 604290567
23607bed9-64f3-4b14-9b4d-7cc70dc8b185 (view SPL)Estazolam Tablets CIV Revised: September 2008 Rx only 14444-2prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-201216950220
350914a46-eab6-4c83-97cf-6ab0234c8126 (view SPL)ESTAZOLAM TABLETS CIV 01290130 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-036000930129, 000930130
4a1e3b4bf-22e9-430a-a768-4d86ae886c9e (view SPL)Estazolam Tablets CIV Revised: September 2008 Rx only 14444-2prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2010-11-236005910744, 005910745

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