Application 071422

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 100MG BASENoNo
002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 25MG BASENoNo
004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo
005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
006DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071422-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-09
A071422-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-09
A071422-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-09
A071422-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-09
A071422-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1987-11-09
A071422-006DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1987-11-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 253 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071422-001DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A071422-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A071422-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A071422-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A071422-005DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1987-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A071422-006DOXEPIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1987-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A071422-001DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A071422-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A071422-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A071422-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A071422-005DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1987-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A071422-006DOXEPIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1987-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071422-001DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071422-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071422-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071422-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071422-005DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1987-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071422-006DOXEPIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRS1987-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071422-001DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071422-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071422-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071422-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071422-005DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1987-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071422-006DOXEPIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRS1987-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A071422-001DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071422-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071422-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071422-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071422-005DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1987-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071422-006DOXEPIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRS1987-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071422-001DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071422-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071422-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071422-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071422-005DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL1987-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071422-006DOXEPIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALABRS1987-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071422-001DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORAL1987-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071422-002DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL1987-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071422-003DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL1987-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071422-004DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL1987-11-09b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071422-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071422-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071422-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071422-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071422-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071422-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071422-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071422-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071422-006AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071422-006AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071422-006AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071422-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071422-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071422-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071422-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071422-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071422-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071422-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071422-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071422-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071422-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071422-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071422-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071422-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071422-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071422-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071422-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071422-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071422-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071422-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071422-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071422-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071422-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071422-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071422-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071422-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071422-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071422-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071422-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071422-004AB1bb7c543d1eb4…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAppco Pharma LLCabf4c515-8888-4733-80a0-fd4e1cdb84a22021-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPe98f371e-f7fe-4c8f-9491-6eb4c53d43ad2021-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEContract Pharmacal Corp.abbf7078-a012-4e1a-e053-2995a90a792d2020-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC10d9eba6-30d1-448a-8d92-a1a02df033032017-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
PRUDOXINDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.ca53346b-8ab3-4722-98f6-cf272706d3fa2017-06-29Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
ZonalonDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.5f302247-525e-4acc-852b-00eb1d79af4b2017-06-14Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Pharmaceuticals Inc.b4771ea7-c19b-4182-bb23-c1473ab583fa2017-05-24Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6970Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6970Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6971Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6971Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6972Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6972Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6973Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6973Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6973Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6973Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
45865-968Doxepin HydrochlorideDoxepin Hydrochloridemedsource pharmaceuticalsANDACurrent
49884-217Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-217Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-217Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-217Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-218Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-218Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-218Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-218Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-219Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-219Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-219Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-219Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-220Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-220Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-220Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-221Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-221Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-221Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-221Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-221Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-222Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-222Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-222Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-222Doxepin HydrochlorideDoxepin HydrochloridePar Pharmaceutical, Inc.ANDACurrent
63629-2180Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2180Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2180Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2181Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2181Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2181Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2182Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2182Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2182Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
63629-7852Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0642Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent