Application 211603

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
A211603-001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27
A211603-002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27
A211603-003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27
A211603-004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27
A211603-005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211603-001AB
A211603-002AB
A211603-003AB
A211603-004AB
A211603-005AB

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-001DOXEPIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-002DOXEPIN HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-003DOXEPIN HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-004DOXEPIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-005DOXEPIN HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211603-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A211603-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A211603-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211603-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211603-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211603-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211603-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211603-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211603-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211603-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211603-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211603-005AB103ed91905a0d…

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1496dfc1-de50-471c-be87-1f1e2b70ab5a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEAurobindo Pharma Limitedf3c242dd-426e-4c69-8f21-2645361d5f272025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
ndc (product): 59651-176
ndc (product): 59651-177
ndc (product): 59651-174
ndc (product): 59651-173
ndc (product): 59651-175
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2bf7d838-6274-4d8a-91cb-b27e1e81d2732025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
ndc (product): 72789-220
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9ee26b24-7121-3107-e053-2995a90ac61c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
ndc (product): 68071-5179
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LP6ce7fde2-2d47-4238-9beb-555d352f46572022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
ndc (product): 71205-610
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPe98f371e-f7fe-4c8f-9491-6eb4c53d43ad2021-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211603
application number: ANDA211603
ndc (product): 71205-534

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 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-103Doxepin HydrochlorideDoxepin HydrochlorideMedsource PharmaceuticalsANDACurrent
55700-768Doxepin HydrochlorideDoxepin HydrochlorideQuality Care Products, LLCANDACurrent
55700-768Doxepin HydrochlorideDoxepin HydrochlorideQuality Care Products, LLCANDACurrent
55700-783Doxepin HydrochlorideDoxepin HydrochlorideQuality Care Products, LLCANDACurrent
55700-783Doxepin HydrochlorideDoxepin HydrochlorideQuality Care Products, LLCANDACurrent
55700-831Doxepin HydrochlorideDoxepin HydrochlorideQuality Care Products, LLCANDACurrent
59651-173Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-173Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-173Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-174Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-174Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-174Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-175Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-175Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-175Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-176Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-176Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-176Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-177Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-177Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-177Doxepin HydrochlorideDoxepin HydrochlorideAurobindo Pharma LimitedANDACurrent
68071-5179Doxepin HydrochlorideDoxepin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5179Doxepin HydrochlorideDoxepin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5260Doxepin HydrochlorideDoxepin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5260Doxepin HydrochlorideDoxepin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7731Doxepin HydrochlorideDoxepin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7731Doxepin HydrochlorideDoxepin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2274Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2274Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2274Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2371Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2371Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2371Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2401Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2401Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2401Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2468Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2468Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2468Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2519Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2519Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
71205-534Doxepin HydrochlorideDoxepin HydrochlorideProficient Rx LPANDACurrent
71205-610Doxepin HydrochlorideDoxepin HydrochlorideProficient Rx LPANDACurrent
71205-610Doxepin HydrochlorideDoxepin HydrochlorideProficient Rx LPANDACurrent
71335-1450Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1450Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1665Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1665Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
72789-220Doxepin HydrochlorideDoxepin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-220Doxepin HydrochlorideDoxepin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-220Doxepin HydrochlorideDoxepin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent