Application 215483

Type
ANDA
Sponsor
JUBILANT CADISTA

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 43.

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
A215483-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14
A215483-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14
A215483-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14
A215483-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14
A215483-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215483-001AB
A215483-002AB
A215483-003AB
A215483-004AB
A215483-005AB

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 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1484e616aacf4f…
2026-08-18 06:07:402026-07A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2022-03-1403ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215483-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A215483-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A215483-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215483-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215483-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215483-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215483-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215483-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215483-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215483-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215483-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215483-005AB103ed91905a0d…

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 3 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxepin hydrochlorideDOXEPIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.554ab06f-6420-42b3-89d1-d97554c237d82025-08-06Warnings, Adverse reactionsName fallback
brand name: doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDELifestar Pharma LLCfdaf3bd7-c456-40bd-8bc3-2b67eb1846c82025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEMylan Institutional Inc.137a953b-3c48-405f-86a6-ff778cb7f5f22025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEAlembic Pharmaceuticals Inc.4920401a-cde5-404b-82aa-c3c0e89110652025-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
DoxepinDOXEPIN HYDROCHLORIDEBryant Ranch Prepack207bb11e-6029-4506-92d2-2d8a776b94082025-05-02Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
DoxepinDOXEPIN HYDROCHLORIDEBryant Ranch Prepackbc3b0401-df4a-46a2-a29b-3d70e72aa88b2025-05-01Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDERising Pharma Holdings, Inc.66c6af99-9909-4b18-a43b-898a1c4a34d72025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DoxepinDOXEPIN HYDROCHLORIDEStrides Pharma Science Limited399866d5-3fa6-46d0-9c62-492d5997bc4f2025-03-21Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack3bc72772-22ae-4f29-97ff-4a552b4df6d02025-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack06e027bb-516d-4a1d-b5a0-a66c051eb3672025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEdirect rxb56cdaee-6187-c763-e053-2995a90acc3f2025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2bf7d838-6274-4d8a-91cb-b27e1e81d2732025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf900bac4-02f2-6bf3-e053-6394a90a21612024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEGolden State Medical Supply, Inc.00ef7d0b-4bb9-cd5b-e063-6294a90abc352024-12-24Warnings, Adverse reactionsName fallback
brand name: Doxepin hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBryant Ranch Prepack19c8ad61-4e4f-4c59-b196-34a4e470459f2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepack13da67ec-370c-4647-8440-80fd55f1398e2024-11-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackeb6954cf-e96b-4e54-961d-6b094384bac92024-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214b6c28-7418-5ebd-e063-6394a90ae8332024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Doxepin Hydrochloride
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale214bae5d-36e2-47ae-e063-6294a90a7ddd2024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOXEPIN HYDROCHLORIDE
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackefcae0f7-3491-470f-beea-1aff221782432024-08-20Boxed warning, Warnings, 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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55700-982Doxepin HydrochlorideDoxepin HydrochlorideQuality Care Products, LLCANDACurrent
59746-700Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-700Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-701Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-701Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-702Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-702Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-703Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-703Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-704Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-704Doxepin HydrochlorideDoxepin HydrochlorideJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
72189-388Doxepin HCLDoxepin HCLDirect_RxANDACurrent