Betamethasone Topical Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. (2014-10-02)
Oldest Current Product
1983-08-31
License(s)
NDA, ANDA
RxNORM
TOPICAL OINTMENT\BETAMETHASONE
FDAOB
TOPICAL\OINTMENT\BETAMETHASONE DIPROPIONATE
TOPICAL\OINTMENT\BETAMETHASONE VALERATE
SPL Active
TOPICAL\OINTMENT\BETAMETHASONE DIPROPIONATE
TOPICAL\OINTMENT\BETAMETHASONE VALERATE
SPL Moiety
TOPICAL\OINTMENT\BETAMETHASONE
TOPICAL\OINTMENT\BETAMETHASONE VALERATE

product(s) by strength(s)

betamethasone 0.0005 mg/mg topical ointment

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680056NDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1984-09-04BETAMETHASONE DIPROPIONATETOPICALOINTMENTNDA01914197dde5f5-a865-4af2-b562-8da72c8475f3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004720381ANDAActavis Pharma, Inc.2002-08-26BETAMETHASONE DIPROPIONATETOPICALOINTMENTANDA071012aa3f4012-7597-422d-8bcc-00102780a152

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950614ANDARebel Distributors Corp1987-02-03BETAMETHASONE DIPROPIONATETOPICALOINTMENT004720381ANDA071012389cdebb-55fe-4808-a5b7-0f293d9ee45d
2545691114NDAA-S Medication Solutions Llc1984-09-04BETAMETHASONE DIPROPIONATETOPICALOINTMENT001680056NDA019141701a0510-b75d-43ac-aee0-9e32ed24b391
3548683280NDAPhysicians Total Care, Inc.1994-04-27BETAMETHASONE DIPROPIONATETOPICALOINTMENT001680056NDA019141dc35ba25-8746-4ed8-83c1-e6b6a1057863
4687880972ANDAPreferred Pharmaceuticals, Inc.1987-02-03BETAMETHASONE DIPROPIONATETOPICALOINTMENT004720381ANDA071012686fc300-7cc6-4901-9640-ae60abb7c4de

betamethasone 0.001 mg/mg topical ointment

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680033NDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1983-08-31BETAMETHASONE VALERATETOPICALOINTMENTNDA0188650b386ccc-a2d4-4d18-a2d7-e46ff894c674

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004720371ANDAActavis Pharma, Inc.2002-09-01BETAMETHASONE VALERATETOPICALOINTMENTANDA070051adad8824-bf2e-463d-9609-87b960801eee

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950586NDARebel Distributors Corp2009-10-23BETAMETHASONE VALERATETOPICALOINTMENT001680033NDA018865eeb337ba-0d7e-42cd-840a-78783b5688d7
2545690793ANDAA-S Medication Solutions Llc2002-09-01BETAMETHASONE VALERATETOPICALOINTMENT004720371ANDA0700518da6ffdd-51ea-4ca4-a82c-a51df589decf
3548682994NDAPhysicians Total Care, Inc.1997-05-02BETAMETHASONE VALERATETOPICALOINTMENT001680033NDA01886572bcd320-39d6-49db-bc7b-d140d200076a
4631870276ANDAProficient Rx Lp2002-09-01BETAMETHASONE VALERATETOPICALOINTMENT004720371ANDA0700517fc14c26-2cad-43c5-82c7-ced4cc845292

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070051BETAMETHASONE VALERATEACTAVIS MID ATLANTIC LLC1984-10-10ANDA070051_001
2ANDA070069BETA-VALG AND W LABORATORIES INC1985-12-19ANDA070069_001
3ANDA070486BETAMETHASONE VALERATETruePHARMAFAIR INC1987-05-29ANDA070486_001
4ANDA071012BETAMETHASONE DIPROPIONATEACTAVIS MID ATLANTIC LLC1987-02-03ANDA071012_001
5ANDA071477BETAMETHASONE DIPROPIONATETrueTEVA PHARMACEUTICALS USA INC1987-08-10ANDA071477_001
6ANDA071478BETAMETHASONE VALERATETruePERRIGO NEW YORK INC1987-12-23ANDA071478_001
7ANDA072526BETAMETHASONE DIPROPIONATETruePERRIGO NEW YORK INC1990-01-31ANDA072526_001
8ANDA074271BETAMETHASONE DIPROPIONATETARO PHARMACEUTICALS INC1994-09-15ANDA074271_001
9NDA016740VALISONETrueSCHERING CORPNDA016740_001
10NDA017691DIPROSONETrueSCHERING CORP SUB SCHERING PLOUGH CORPNDA017691_001
11NDA018863BETATREXTrueSAVAGE LABORATORIES INC DIV ALTANA INC1983-08-31NDA018863_001
12NDA018864BETAMETHASONE VALERATETruePHARMADERM DIV ALTANA INC1983-08-31NDA018864_001
13NDA018865BETAMETHASONE VALERATEE FOUGERA DIV ALTANA INC1983-08-31NDA018865_001
14NDA019140BETAMETHASONE DIPROPIONATETruePHARMADERM DIV ALTANA INC1984-09-04NDA019140_001
15NDA019141BETAMETHASONE DIPROPIONATEE FOUGERA DIV ALTANA INC1984-09-04NDA019141_001
16NDA019143ALPHATREXTrueSAVAGE LABORATORIES INC DIV ALTANA INC1984-09-04NDA019143_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070051_001RXBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTFalseAB1984-10-10BETAMETHASONE VALERATE
2ANDA070069_001RXBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTFalseAB1985-12-19BETA-VAL
3ANDA070486_001discontinuedBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1987-05-29BETAMETHASONE VALERATE
4ANDA071012_001RXBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTFalseAB1987-02-03BETAMETHASONE DIPROPIONATE
5ANDA071477_001discontinuedBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTFalse1987-08-10BETAMETHASONE DIPROPIONATE
6ANDA071478_001discontinuedBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1987-12-23BETAMETHASONE VALERATE
7ANDA072526_001discontinuedBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTFalse1990-01-31BETAMETHASONE DIPROPIONATE
8ANDA074271_001RXBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTFalseAB1994-09-15BETAMETHASONE DIPROPIONATE
9NDA016740_001discontinuedBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTFalseVALISONE
10NDA017691_001discontinuedBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTFalseDIPROSONE
11NDA018863_001discontinuedBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1983-08-31BETATREX
12NDA018864_001discontinuedBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1983-08-31BETAMETHASONE VALERATE
13NDA018865_001RXBETAMETHASONE VALERATE (EQ 0.1% BASE)TOPICALOINTMENTTrueAB1983-08-31BETAMETHASONE VALERATE
14NDA019140_001discontinuedBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTFalse1984-09-04BETAMETHASONE DIPROPIONATE
15NDA019141_001RXBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTTrueAB1984-09-04BETAMETHASONE DIPROPIONATE
16NDA019143_001discontinuedBETAMETHASONE DIPROPIONATE (EQ 0.05% BASE)TOPICALOINTMENTFalse1984-09-04ALPHATREX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10b386ccc-a2d4-4d18-a2d7-e46ff894c674 (view SPL)BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-10-025001680033, 001680040, 001680041Betamethasone Topical Cream
Betamethasone Topical Lotion
2389cdebb-55fe-4808-a5b7-0f293d9ee45d (view SPL)BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (potency expressed as betamethasone) For Dermatologic Use Only Not for Ophthalmic Use Rx OnlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-141216950614
3686fc300-7cc6-4901-9640-ae60abb7c4de (view SPL)BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (potency expressed as betamethasone) For Dermatologic Use Only Not for Ophthalmic Use Rx OnlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-05-306687880972
4701a0510-b75d-43ac-aee0-9e32ed24b391 (view SPL)BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691114, 545691113Betamethasone Topical Cream
572bcd320-39d6-49db-bc7b-d140d200076a (view SPL)BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-10-231548682994, 548680520, 548685002Betamethasone Topical Cream
Betamethasone Topical Lotion
67fc14c26-2cad-43c5-82c7-ced4cc845292 (view SPL)BETAMETHASONE VALERATE CREAM, USP 0.1% BETAMETHASONE VALERATE OINTMENT, USP 0.1%prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870276
78da6ffdd-51ea-4ca4-a82c-a51df589decf (view SPL)BETAMETHASONE VALERATE CREAM, USP 0.1% BETAMETHASONE VALERATE OINTMENT, USP 0.1%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545690793
897dde5f5-a865-4af2-b562-8da72c8475f3 (view SPL)BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2013-08-077001680056, 001680055, 001680057Betamethasone Topical Cream
Betamethasone Topical Lotion
9aa3f4012-7597-422d-8bcc-00102780a152 (view SPL)BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%prescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2010-04-012004720381
10adad8824-bf2e-463d-9609-87b960801eee (view SPL)BETAMETHASONE VALERATE CREAM, USP 0.1% BETAMETHASONE VALERATE OINTMENT, USP 0.1%prescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2010-11-032004720371, 004720370Betamethasone Topical Cream
11dc35ba25-8746-4ed8-83c1-e6b6a1057863 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-01-035548683280, 548680973Betamethasone Topical Cream
12eeb337ba-0d7e-42cd-840a-78783b5688d7 (view SPL)BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-221216950586

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