Application 210614

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210614-001NIFEDIPINENIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12
A210614-002NIFEDIPINENIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12
A210614-003NIFEDIPINENIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB2RS2019-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210614-001AB2
A210614-002AB2
A210614-003AB2

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22019-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22019-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210614-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22019-03-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210614-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210614-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210614-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210614-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210614-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210614-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210614-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210614-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210614-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210614-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210614-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210614-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A210614-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210614-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210614-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210614-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210614-001AB218072bd15b7f6…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NifedipineNIFEDIPINESt. Mary's Medical Park Pharmacy1add684f-d082-72cc-e063-6394a90a12142026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINESt. Mary's Medical Park Pharmacy1ab8945b-bea5-9827-e063-6294a90af3342026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEBryant Ranch Prepacke1cd5011-b80e-4b1b-8729-56260b8b3c262026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 71335-1721
NifedipineNIFEDIPINECoupler LLC518d39af-0be1-acbc-e063-6294a90a4ada2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEMajor Pharmaceuticals41aa6fbd-96c1-40f7-92d4-cfdd2d5325e92026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 0904-7080
ndc (product): 0904-7081
ndc (product): 0904-7082
NifedipineNIFEDIPINEIngenus Pharmaceuticals, LLC4d3e11d2-d320-45d3-96c8-48322202b5042026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 50742-262
ndc (product): 50742-261
ndc (product): 50742-260
NifedipineNIFEDIPINECardinal Health 107, LLCc98ecf77-ae9a-438b-9bad-ffbed25d95bc2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 55154-4157
NifedipineNIFEDIPINEA-S Medication Solutions446505e8-cd68-4037-bebe-954a893dc67b2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 50090-6201
NifedipineNIFEDIPINEA-S Medication Solutions3334ab6f-aeb0-4b78-8d17-f0aedd94f9962026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 50090-6203
NifedipineNIFEDIPINEREMEDYREPACK INC.24e56333-5601-48fd-a263-f6be90983fb42026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 70518-2679
NifedipineNIFEDIPINENorthwind Health Company, LLCf8358be1-848c-d9eb-e053-6294a90a178c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINENorthwind Health Company, LLCf2f3564a-d43a-6c36-e053-2a95a90ae8782026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINENorthwind Health Company, LLCf32c0fc9-b4ad-6a1f-e053-2995a90acf612026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEA-S Medication Solutions9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd442025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
NifedipineNIFEDIPINEPreferred Pharmaceuticals Inc.cda16a27-f029-40a6-a0e8-2bed0de711692025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 68788-8164
NifedipineNIFEDIPINEPreferred Pharmaceuticals, Inc.4ee466dc-5a4e-4c77-8e94-8b510cafd61b2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 68788-7642
NifedipineNIFEDIPINEREMEDYREPACK INC.832fc274-605a-4b04-b327-dbf3611316212025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 70518-3520
NifedipineNIFEDIPINEBryant Ranch Prepack325acf27-4b2e-40e8-8344-bb6cc99599102025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 71335-1550
NifedipineNIFEDIPINENuCare Pharmaceuticals,Inc.d5df10bc-16ed-7a97-e053-2a95a90ab15e2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614
ndc (product): 68071-2619
NifedipineNIFEDIPINENCS HealthCare of KY, LLC dba Vangard Labs0cabe053-3b7e-4dcb-8441-ef7821bb6f682024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210614
application number: ANDA210614

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7080NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7080NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7081NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7081NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7081NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7082NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7082NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7082NifedipinenifedipineMajor PharmaceuticalsANDACurrent
50090-6201NifedipinenifedipineA-S Medication SolutionsANDACurrent
50090-6203NifedipinenifedipineA-S Medication SolutionsANDACurrent
50742-260NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-260NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-260NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-261NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-261NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-261NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-262NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-262NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-262NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
55154-4157NifedipinenifedipineCardinal Health 107, LLCANDACurrent
68071-2619NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7642NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7642NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7642NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8164NifedipinenifedipinePreferred Pharmaceuticals Inc.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-3520NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-3520NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
71335-1550NifedipinenifedipineBryant Ranch PrepackANDACurrent
71335-1550NifedipinenifedipineBryant Ranch PrepackANDACurrent
71335-1721NifedipinenifedipineBryant Ranch PrepackANDACurrent
71335-2132NifedipinenifedipineBryant Ranch PrepackANDACurrent