Application 206641

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	No	No
004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	No	No
005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	360MG	No	No
006	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	420MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206641-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11
A206641-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11
A206641-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11
A206641-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11
A206641-005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11
A206641-006	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A206641-001	AB4
A206641-002	AB4
A206641-003	AB4
A206641-004	AB4
A206641-005	AB4
A206641-006	AB4

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206641-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206641-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206641-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206641-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206641-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206641-006	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206641-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206641-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206641-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206641-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206641-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206641-006	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206641-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206641-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206641-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206641-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206641-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206641-006	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206641-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206641-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206641-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206641-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206641-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206641-006	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206641-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206641-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206641-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206641-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206641-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206641-006	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206641-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206641-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206641-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206641-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206641-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206641-006	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206641-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206641-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206641-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206641-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	2017-08-11	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206641-003	AB4	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206641-004	AB4	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206641-005	AB4	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206641-006	AB4	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206641-001	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206641-002	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206641-003	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206641-004	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206641-005	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206641-006	AB4	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206641-001	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206641-002	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206641-003	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206641-004	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206641-005	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206641-006	AB4	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206641-001	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206641-002	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206641-003	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206641-004	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206641-005	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206641-006	AB4	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206641-001	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206641-002	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206641-003	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206641-004	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206641-005	AB4	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206641-006	AB4	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206641-001	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206641-002	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206641-003	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206641-004	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206641-005	AB4	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206641-006	AB4	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206641-001	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206641-002	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206641-003	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206641-004	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206641-005	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206641-006	AB4	1	`74a2ff9319b5…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIADYLT ER	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	b4b4e53e-fc99-4f34-abc2-57e4f28aff84	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206641 application number: ANDA206641
TIADYLT ER	DILTIAZEM HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	1278cd76-b8e9-42d9-ad19-6858e72cf9f2	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206641 application number: ANDA206641 ndc (product): 68382-749 ndc (product): 68382-745 ndc (product): 68382-750 ndc (product): 68382-748 ndc (product): 68382-746 ndc (product): 68382-747
TIADYLT ER	DILTIAZEM HYDROCHLORIDE	Zydus Lifesciences Limited	d88e3546-3984-4dc9-893a-a29e95804550	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206641 application number: ANDA206641 ndc (product): 70771-1040 ndc (product): 70771-1036 ndc (product): 70771-1038 ndc (product): 70771-1037 ndc (product): 70771-1039 ndc (product): 70771-1035

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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-745	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-745	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-745	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-746	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-746	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-746	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-747	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-747	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-747	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-748	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-748	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-748	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-749	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-749	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-749	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-750	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-750	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-750	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1035	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1035	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1035	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1036	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1036	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1036	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1037	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1037	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1037	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1038	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1038	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1038	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1039	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1039	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1039	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1040	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1040	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1040	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49481	ORIG	2017-08-21