Application 207482

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207482-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28
A207482-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28
A207482-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28
A207482-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28
A207482-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A207482-001AB
A207482-002AB
A207482-003AB
A207482-004AB
A207482-005AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-06-282680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207482-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207482-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207482-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207482-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207482-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207482-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207482-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207482-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207482-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207482-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207482-005AB12680178bc6a6…

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutions78cf65ff-43f9-4f5e-95dd-864acc89c02a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDERedpharm Drug37451a61-ccb1-57b3-e063-6294a90a25922025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMajor Pharmaceuticalsdf3b6be0-6a64-4174-b351-dab2061f290e2025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
ndc (product): 0904-7055
ndc (product): 0904-7052
ndc (product): 0904-7053
ndc (product): 0904-7054
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack3bc72772-22ae-4f29-97ff-4a552b4df6d02025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
ndc (product): 71335-0072
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLC20bfb8af-7933-4e5c-a2b5-010659d9125b2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207482
application number: ANDA207482
ndc (product): 69238-1166
ndc (product): 69238-1172
ndc (product): 69238-1170
ndc (product): 69238-1173
ndc (product): 69238-1171

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7054Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7054Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7054Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7055Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7055Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7055Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
61919-863DOXEPIN HCLDOXEPIN HCLDirect_RxANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
70518-1380Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1380Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1412Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1412Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0072Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0072Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0072Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0780Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0780Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48880ORIG2017-06-30