Application 203851

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION1,000 UNITS/MLNoNo
002HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/MLNoNo
003HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203851-001HEPARIN SODIUMHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30
A203851-002HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30
A203851-003HEPARIN SODIUMHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203851-001AP
A203851-002AP
A203851-003AP

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-301e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203851-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203851-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203851-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203851-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203851-001AP11e350fbaab3a…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMMylan Institutional LLC88114716-5759-4bc9-8a85-d28da12962cc2025-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203851
application number: ANDA203851
ndc (product): 67457-384
ndc (product): 67457-385
ndc (product): 67457-383
ndc (product): 67457-603
ndc (product): 67457-374
ndc (product): 67457-602
ndc (product): 67457-372

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 88 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9873HEPARIN SODIUMheparin sodium injectionHenry Schein, Inc.ANDACurrent
0404-9873HEPARIN SODIUMheparin sodium injectionHenry Schein, Inc.ANDACurrent
0404-9873HEPARIN SODIUMheparin sodium injectionHenry Schein, Inc.ANDACurrent
52584-116HEPARIN SODIUMheparin sodium injectionGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-116HEPARIN SODIUMheparin sodium injectionGeneral Injectables and Vaccines, Inc.ANDACurrent
67457-372Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-372Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-372Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-372Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-374Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-374Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-374Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-374Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-383Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-383Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-383Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-383Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-384Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-384Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-384Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-384Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-385Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-385Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-385Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-385Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-602Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-602Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-602Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-602Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-603Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-603Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-603Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-603Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-948Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-949Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-950Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-952Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-953Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-954Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-954Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-954Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-954Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-954Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-954Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent
67457-954Heparin SodiumHeparin SodiumMylan Institutional LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50578ORIG2017-12-01